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Candidate Info
Nursing (bsn)
Drug Safety Associate "clinical Trials"
Collected and reconciled AE data between the safety and the clinical databases. Responsible for creating queries to sites and clarifying safety information. Provided adverse event training to clinical research associates and investigator sites.
- Supervised inspection of medical devices and responsible or Medical Device Reporting (MDR) and made
- Created new AE reconciliation process that decreased reconciliation time by 10% - 15%.
- Oversaw reconciliation of data in safety and clinical databases which lead to early filing of IND.
- Supervised clinical research associates collection of AE data.
Candidate Info
Certificate
Retail & Customer Service Training Program
Medical Assistant (diploma)
Business
Management Training
Global Operations Drug Safety Associate
Increased customer satisfaction by expediting queries with effective and precise resolution.
- Administered the entry and revision of applicable information into the global safety database for initial or follow-up reports received via paper, fax or email. Accepted cases submitted via E2B as applicable.
- Ensured regulatory compliance for individual expedited cases and case report submissions to Health Authorities or other receivers as appropriate. Accepted E2B cases received through Argus Electronic Submission Module (ESM) as necessary and processed prior to routing to PSSR.
- Reduced case backlog within timelines which saved the company from being fined by the FDA.
- Utilized expertise in safety systems to investigate status of reports and perform database queries for reconciliation purposes.
- Participated in cross-functional training to ensure adherence to organizational policies and procedures.
- Performed quality review and checking cases for discrepancies for any errors related to labeling and narrative writing.
Candidate Info
Bachelor of Science
Bachelor of Arts
Drug Safety Associate
Reviewed Serious Adverse Events (SAEs) generated for post marketed litigation for accuracy and completeness.
- Updated and entered appropriate data into Clinical database and ensured data was captured according to departmental SOPs.
- Ensured accuracy of coding, which includes selecting appropriate event terms in MedDRA and worked closely with the coding department.
- Wrote narratives summarizing the events according to departmental SOPs for spontaneous and literature cases through assessment of all source documents.
- Communicated closely with clinical investigators to ensure accuracy of data, which included generating and resolving queries.
- Communicated daily with client and management staff to ensure timely completion of tasks and supported established departmental objectives.
- Technical skills include Microsoft Office Suite, Word, Power Point, Excel and MedDRA coding.
Candidate Info
year in workforce
year at this job
Science
Psychology
Nursing
Contract Position A Drug Safety Associate at Bracco Diagnostics
Entered preliminary and follow-up information received via mail, telephone, and electrical source documents into a global electronic adverse event database (ClinTrace).
- Reviewed, processed, coded, and submitted serious and non-serious adverse event reports for spontaneous and sponsored studies, in compliance with global regulations and compliance timelines.
- Utilized medical terminology, MedDRA coding terms and obtained detailed information in prevention of quality assurance discrepancies.
- Prepared narratives for MedWatch (FDA 3500A) and CIOMS forms for domestic and international cases.
- Logged reports for tracking of contrast media adverse events in lotus notes application (WALNOT) within the Drug Safety and Pharmacoepidemiology (DSP) Unit.
- Contributed to the improvement of the electronic safety database and filing system by maintaining filing system integrity for report hardcopy, and performing accurate database searches.
- Assisted in the preparation of SOPs, Aggregate Reports (PSURs), preparing line listing reports and summary tabulations tracked with document control including training materials, and maintained currency of SOPs.
Candidate Info
years in workforce
months at this job
Gcp / Ich
Certificate
Drug Safety Associate
Case Processing: - performed case receipt, case triage and processed adverse event using Argus.
- Performed follow-up via telephone contact with health care professionals
- Coding relevant medical terminology, composed descriptive narrative and generated advanced condition queries.
- Quality control check of adverse event for accuracy and completeness.
- Prepared safety reports and utilized regulatory and medical knowledge to assess claims.
Candidate Info
Master of Business Administration
Pharmaceutical Sciences (bachelors)
Drug Safety Associate
Responsible for medical entry, medical assessment, meddra coding of events, case narratives
- Responsible for QC of case processing and submission guidance in finalized cases from all therapeutic areas
- Trained and mentored peers in case processing methodologies, as per regulations and local SOPs
- Ensured compliance by informing senior management of any process gaps with respect to FDA regulations, viz. changes in [company name] regulations and guidelines for marketed and investigational products, and recommended changes where applicable
- Participate in bi-weekly status meetings
Candidate Info
Pharmacy
Music
Drug Safety Associate
Coded, assessed, and performed follow-up for adverse event cases in accordance with federal and ICH regulations and drug safety SOPs.
- Developed enhanced case processing flow for PDSO as part of project team
- Presented training session to operation team on enhanced case process workflow
- Lead Trainer for monthly Adverse Event Reporting class for Roche Sales Representatives and Account Managers
- Provided Drug Safety Operations guidance as team member of Tamiflu
- SME for Xeloda
- Trained vendors in Adverse Event reporting for pregnancy registry as part of REMS
Candidate Info
years in workforce
year at this job
Nursing
Ceramic Science And Engineering
Polymer Science
Drug Safety Associate
Entered appropriate data in Oracle Clinical database according to SOPs, selected appropriate event terms in MedDRA and wrote narratives summarizing the events.
- Reviewed spontaneous case reports concerning adverse events and serious adverse events to ensure accurate data capture according to departmental SOPs.
- Reviewed and updated clinical trial case report forms concerning serious adverse events for completeness and accuracy.
- Conducted follow-up queries with clinical investigators regarding incomplete or unclear data.
- Performed secondary and auxiliary data review and SAE reconciliation.
Candidate Info
years in workforce
years at this job
Nursing
Senior Drug Safety Associate
Directed collection, data entry, coding, routing, follow-up, and timely reporting and submission of spontaneous, foreign and literature safety information in compliance with FDA regulations.
- Trained and mentored new drug safety associates, providing supervision and teaching key skills in Drug Safety.
- Handled initial and follow-up pharmacovigilance transactions from consumers, health care professionals, and attorneys, as necessary, in accordance with Forest policy and procedures.
- Assigned and completed expedited cases to ensure regulatory and client deadlines were met.
- Informed appropriate staff of delayed, missing or incomplete items; established follow-up procedures and completed all transactions in a timely manner.
- Minimized risk through active collaboration with Quality Standards and interfacing with management as needed.
- Expertise in safety system experience and case processing, interfacing with teams formed to assess the continuing safety profile for the compound or product.
Candidate Info
Certificate
Nursing (vocational)
Clinical Drug Safety Associate
Processed serious adverse events (SAEs) for clinical trials within Clintrace database per departmental standard operating procedures, including assessing reportability and coding/labeling in accordance with FDA and GCP/ICH guidelines
- Liaison to CROs for Safety Management of Clinical Trials
- Drafted investigator IND letters, reviewed regulatory packets including analysis of similar events for expedited SAE's to be reported across protocols for the same compounds
- Executed test scripts for database implementation validation project
- Prepared working instructions for the SAE/AE Reconciliation Process and actively participates in the reconciliation of Safety and Clinical databases
- Participated in preparing IND Annual Reports
Candidate Info
years in workforce
years at this job
Nursing
Psychology
Drug Safety Associate
Reported adverse events to FDA according to ICH guidelines related to (postmarketed) litigation drugs/vaccines. Perform void/consolidations, mixed and split document case reporting using MedDRA coding, WHO-DRL, using Argus.
- Authored safety narratives and prepared adverse event reports for medical review and submission to regulatory authorities
- Managed timely case processing to ensure PSUR deadlines
- Reconciled reports of product quality complaints associated with adverse events and all other spontaneous adverse events with Quality Assurance and Medical Information departments
- Requested follow-up information concerning adverse event reports as appropriate
- Triaged and analyzed adverse event information for entry into the adverse event tracking and reporting system
- Coded and classified adverse event reports according to regulations and department SOPs
Candidate Info
year in workforce
year at this job
Bachelor of Arts
Biologics And Medical Devices
Drug Safety Associate in The Department of Pharmacovigilance
Performed case triaging and case processing.
- Performed the initial review of ancillary documentation accompanying Individual case Safety reports.
- Assessed case report for seriousness, causality and expectedness.
- Collected, processed follow-up, analysis, and regulatory reporting of adverse event and serious adverse events for marketed products and investigational products by using Arisg database.
- Managed case related information including lab results, and procedures as well as compiled complete narrative summaries.
- Maintained consistency of safety assessment.
Candidate Info
years in workforce
years at this job
Nursing
Senior Drug Safety Associate
Collected, documents, and processed adverse event (AE) reports from clinical trials adhering to Standard Operating Procedures.
- Prepared clinical narrative summaries for 'Adverse Event'.
- Performed active follow-up via telephone contact with consumers and healthcare professionals.
- Ensured timely coverage to Regulatory Authorities and pharmacist.
- Participated in preparing safety reports and maintained clinical databases.
- Perform Medical review of Individual cases safety reports to determine Relatedness, Causality assessment, case finalization and Reportability.
- Wrote and corrected Narratives for FDA submissions.
- Liaised with assigned Physicians in Drug Safety, Clinical Science and/or MedSA to ensure that appropriate medical review and assessment is provided for assigned case reports
Candidate Info
Biological Sciences (bachelors)
Drug Safety Associate Consultant
Was assigned to Astellas Pharmaceuticals (Deerfield IL) pharmacovigilance department
- Managed the initial assessment and distribution of adverse event triage case assignments to the pharmacovigilance group
- Provided follow-up phone calls to consumers for clarification of adverse event data
- Performed literature analyses of spontaneous adverse events case reports and post-marketing clinical trials and writing of case narratives
- Supported medical information group in various projects as assigned
Candidate Info
Exercise Physiology & Nutritional Science (postgraduate Diploma)
Research Assistantship
Microbiology And Biotechnology (bsc (hons))
Senior Drug Safety Associate
Reviewed and processed case reports to resolution, including triage, case entry and follow-up contact with case reporters.
- Assisted in the preparation of Periodic Safety Update Reports, 7- and 15-day IND safety reports and safety update reports, including narrative writing.
- Evaluated adverse event reports to determine reporting requirements and identify safety signals.
- Participated in the SAE reconciliation between Safety and Clinical databases.
- Reported adverse events to IRB, EMEA & FDA.
- Worked with internal IT designer to improve design and CFR 11 compliance of internal Drug Safety database.
Candidate Info
years in workforce
years at this job
Pharmacy
Chemistry
Drug Safety Associate
Entered and validated adverse event related information in drug safety database for investigational and post-marketing products.
- Created comprehensive narratives procured from relevant, related information from various source documents.
- Generated requests for follow-up information.
- Provided follow-up on adverse event cases by preparing, sending out and tracking queries to reporters.
- Managed Case-related information including interpretation of medical conditions, lab results, and procedures.
- Prepared all critical study related documents, performed regulatory and ethical submissions and communicated with relevant authorities.
- Review of all cases in accordance with GCP and other regulatory guidelines.
- Collaborated with internal departments and investigative clinical research sites to ensure compliance with safety processes.
- Maintained working knowledge of regulatory strategy and current regulations in the pharmaceutical industry.
Candidate Info
years in workforce
years at this job
Pharmacy / Allied Health / Clinical
Education
Drug Safety Associate
Adhered to and enforced federal guidelines.
- Performed clinical assessments of medical charts in adverse events.
- Carried out detection and analysis.
- Generated commentaries and reported to federal authorities.
- Implemented strong clinical communication skills and use of computerized systems.
Candidate Info
years in workforce
months at this job
Drug Safety Associate
Triage of incoming cases to determine seriousness for prioritization of daily workflow.
- Processing of adverse events (includes receipt, assessment of Listedness, seriousness criteria / labeling, case prioritization and request follow-ups) based on regulatory requirements.
- Performed the initial review of SAEs including assessment of drug-relatedness and expectedness, coding of the events using MedDRA dictionary and the writing narratives.
- Reviewed source documentation, assessing cases for reportability, accurate data entry, and quality check.
- Written clinical narrative summaries independently for SAE/AE reports from clinical studies and spontaneous post-marketing reports and formulated follow-up information requests.
- Performed active follow-up via telephone contact with consumers and health care professionals.
- Ensured timely reporting of SAEs/AEs to Regulatory Authorities, and cross-reporting to pharmaceutical partner(s).
Candidate Info
years in workforce
year at this job
Chemistry
Drug Safety Associate
Received and entered adverse drug events, as well as follow-up from vendors, clinical trials, and spontaneous complaints from consumers, and healthcare providers into both argus and arisg databases.
- Managed data from both postmarket as well as clinical trials according to specific regulations and guidelines
- Responsible for initial triaging of cases coming from the US drug safety intake.
- Reviewed, ranked, verified, processed, and documented case-related information: event terms, validity, seriousness, special scenarios, timeline, accuracy and consistency effectively using both MedDRA coding as well as WHO-DD to report necessary items.
- Reconciled with all internal and external reporters accurately and promptly
- Handled determination of local submission of individual, and where appropriate, aggregate safety reports
- Proficiently wrote and, where necessary edited the case narratives of each adverse drug event received
- Liaised with key partners, locally and other stakeholders regarding safety data collection and data reconciliation
- Determined reportability of scheduled reports, always ensuring adherence to regulatory requirements, as well as internal SOPs
Candidate Info
Bachelor of Science
Clincial Research)
Medicine And Surgery (mbbs)
Lead Clinical Research Associate/ Drug Safety Associate
Lead Coordinator for multicenter neonatology research working with patients in the NICU as well as outpatient clinics.
- Participated in periodic review and updating of SOPs and working practices to ensure they remain compliant
- Assess Safety reports for report ability to authorities and create comprehensive narrative for all adverse events that have occurred across sites for review by medical team
- Effectively collaborated with other relevant departments (Clinical Operations, Data Management, Quality, Regulatory Affairs ) in safety-related activities including clinical site training and performance monitoring, reconciliation, expedited reporting and development/adherence to quality standards
- Conducted thorough review of medical chart/records to track all changes in any therapies and overall medical condition of patient
- Obtained, processed and reported adverse event data in accordance with SOP and IRB guidelines within given timelines.
Candidate Info
Bachelor of Science
College Preparatory
Drug Safety Associate
Processed serious adverse events and follow ups per SOP and FDA guidelines
- Contributed as part of a global medical team in compliance to domestic and international laws
- Performed tasks unique to each sponsor expeditiously in a tight time frame.
- Communicated with manufacturers, administrators, medical monitors, project
Candidate Info
years in workforce
years at this job
Economics And Mathematics
Nursing
Research
Drug Safety Associate
Responsible for comprehensive adverse event report case management and safety issues in compliance with corporate Sop's and worldwide regulatory timelines.
- Processed adverse experience reports for both marketed and investigational products for the Food and Drug Administration and for worldwide regulatory agencies. Duties included tracking, reviewing, coding, computer entry, preparation of final reports and the submission.
- Reviewed literature articles for Merck products. Assessed the need for further processing or the need to send the articles to contacts in other countries for data entry in order to meet strict timelines.
- Requested documents from numerous departments, processed relevant AE information and submitted multiple NDA submissions within required timelines including VARIVAX, MMR II and PROQUAD.
- Validated lot numbers when available and emailed other sites worldwide to obtain US lot equivalent numbers when necessary.
- Performed end of study unblindings.
- Informed the team monthly on SOP updates.
Candidate Info
years in workforce
months at this job
Pharmacy
Analytical Chemistry
Drug Safety Associate
Processing of adverse events (Triage process) data for investigational and spontaneous AE reports.
- Recording of questions, adverse events and complaints from consumers and reporters.
- Reviewing, evaluating and summarizing information in a written document and initiating investigations if required.
- Creating of new cases, searching for duplicate cases and extract information from the database.
- Generating of the case narratives and coding of events in MedDRA, and generation of Medwatch.
- Using internet or electronic databases to mail the inquiries and appropriately respond and to search for the published literature on the company products.
- Adverse event report processing (for pre and post marketed studies) within 24 hour limitation to meet with the regulatory requirements for FDA and ICH guidelines etc.
Candidate Info
years in workforce
years at this job
Nursing
Drug Safety Associate
Documented and processed Serious Adverse Event Reports within company and sponsor timelines in accordance with FDA regulations
- Utilized clinical record data to create detailed safety narratives for serious adverse event reports for submission to pharmaceutical sponsor and FDA
- Issued extensive written queries and liaised with investigational sites to obtain follow up information for completion of reports
- Created project-specific training materials utilized in the training of new team members
- Provided education of study coordinators/CRAs in SAE reporting guidelines according to FDA/Sponsor conventions
- Managed SAE report processing for over 200 clinical sites in international phase IV clinical trial for anemia/chronic kidney disease/diabetes
- Liaised with Sponsors/Project Managers to establish and maintain SAE reporting system for over 25 Phase I-II Clinical Trials
- Served as key point of contact for study coordinators in SAE reporting questions
- Proficient in use of ARIS-g Safety Database
Candidate Info
years in workforce
months at this job
Associate of Science
Business Management
Teaching
Drug Safety Associate
- Performed initial safety review to ensure drug safety.
- Supported clinical operations team on technical matters.
- Created well written regulatory reports on each case study.
- Conducted follow-up querying with reporter to clarify data for accuracy as well as capture additional relevant data.
Candidate Info
Applied And Industrial Biotechnology
Regulatory Affairs For Drugs, Biologics And Medical Devices (masters)
Bioscience Management (certificate)
Pharmacy (bachelors)
Drug Safety Associate
- Managed processing of adverse events and product complaints from clinical trial/post-marketing source for Pfizer AERS, USA
- Performed data entry into ARGUS safety database and triaged adverse events for accuracy and quality
- Coded all adverse event terminology and drug information utilizing MedDRA and WHO-DD dictionaries
- Created, edited draft narratives and generated follow-up queries based on missing clinically significant information
Candidate Info
years in workforce
months at this job
Biology
Drug Safety Associate/ Department Coordinator
- Processed adverse event complaints in Argus Drug Safety Database
- Performed telephone intake and follow-up with consumers
- Interfaced with all levels of health care professionals to assess adverse event cases
- Assisted with the daily functions of the Department Coordinator; i.e. Reviewed and reconciled incoming AE/QD information to determine required action, acknowledged receipt of complaint information from applicable partners, forwarded complaints received related to non-Watson products to the appropriate company, organized and managed the file room
- Assisted with cataloging literature articles in online database (EOS International)
Candidate Info
Drug Safety Associate
Generated Periodic reports, BI-monthly and weekly reports for NCH and affiliates
- Entered consumer information into database and coded adverse events using MedRA coding conventions for monograph products.
- Routed 15 day cases for submission to FDA and maintained serious case tracking tool.
- Compiled serious case reports for medical safety experts review
Candidate Info
Pharmaceutical Management And Leadership (ms)
Biological Sciences (bs)
Biology Pre (as)
Drug Safety Associate
Worked with Case Managers (Registered Nurses, Medical Doctors, Licensed Clinical Social Workers) in the Clinical studies to process critical cases.
- Translated and Reviewed patients' cases/documents - received concurrent reviews and documented all items.
- Proofread documents and carried out need editing and corrections
- Routing of all serious and non-serious adverse events received from physicians
- Entered clinical data accurately into template (name, medications, changes, adverse events, etc.)
- Contacted Health Care Facilities to give authorization for patients, after thorough review
Candidate Info
Nursing (bs)
Drug Safety Associate
Processed generic medical inquiries, product inquires and adverse event information received from consumers and health care professionals related to Actavis products.
- Performed initial assessment and triage of post-marketing adverse events received from consumers and health care professionals and forwarded to supervisor possible expedited cases for assessment.
- Obtained follow up information from consumers and health care professionals.
- Performed data entry, MedDra coding, created narrative and entered data into Oracle AERS database.
- Reviewed Reactions Weekly Newsletter for SAEs and processed expedited cases for submission to the FDA.
- Assisted in the update of Medical Affairs SOP's.
- Responsible for the orientation and training of new staff members.
- Created a Quality Control checklist for cases entered into Oracle AERS.
Candidate Info
years in workforce
months at this job
Bachelor of Arts
Computer Information
Pharmaceutical Science
Drug Safety Associate
Experience in preparation, interpretation, and data entry of adverse events reports into the global safety database (Argus versions 5.0; 5.2) for global distribution.
- Good working knowledge of Clinical trials data like Demographic data, discrepancy, adverse events, serious adverse events, Laboratory data, vital signs.
- Data management skills like Merging, Handling missing values, Reading Raw data files, creating data structures, Accessing and managing data, Appending, Concatenating and interleaving of SAS data sets.
- Process and evaluated foreign and domestic Individual Case Safety Reports(ICRs) of Marketed and Non-Marketed drugs for submission as per regulatory requirements.
- Assisted in developing, editing, organize, submission of data sets to regulatory bodies.
- Oversee confidential data bases for clinical information as well as data from selected Case Report Forms, research studies and administrative projects.
- Triaged case base for Seriousness/Non Seriousness/Fatality of Individual Case Safety Reports (ICSR)
- Generated CIOMS/Med watch for submission and report to concern regulatory bodies..
- Subject matter expert for suppliers and stakeholders, locally, concerning safety-related issues; liaised with key partners (e.g., BUs, License Partners) regarding safety data collection and handling
Candidate Info
years in workforce
years at this job
Basic Pathophysiology
Medical Terminology Training
Drug Safety Associate
Processed adverse event reports in accordance with Standard Operating Procedures and guidelines.
- Prepared narrative summaries.
- Performed quality review of peer's reports.
- Developed expertise on all assigned products.
Candidate Info
Certificate
Computer Technology
Drug Safety Associate
Database Administrator for ARISg database
- Responsible for first entry of Serious Adverse Events into the ARISg Safety Database.
- Reconciled Drug Safety database and the Data Management database
- Maintained tracking logs
- Performed electronic and manual coding using the MedDRA and Who-Art coding dictionaries.
- Performed q/c and entry of narrative writing of patient/subject adverse events
- Assisted in the preparation of tables for the periodic and annual report by conducting systematic querying of the Safety Database.
Candidate Info
Clinical Research
Management Information Systems (mba)
Medical (bachelors)
Nursing Curriculum
Project Management Curriculum
Drug Safety Associate/ Senior Safety Analyst
Generated SAE Reports for Women's Health, CNS, Biologics, Oncology and OTC Products for FDA submission
- Review Medical Documentation for Legal Cases and provided narrative summaries
- Prepared Safety Reports as required (MedWatch and CIOMS)
- Performed data searches utilizing data warehouses and Sceptre, Trackwise, Lincoln (FDA & Who) and SATRE
- Experience writing Product Safety Update Reports (PSUR)
Candidate Info
Pharmacy (bs)
Drug Safety Associate
- Assessed and processed domestic and international adverse event reports
- Contacted health professionals and clinical trial staff to obtain pertinent information about adverse event reports
- Prepared New Drug Application and Investigational New Drug Application Annual Reports for FDA submission
- Reviewed co-workers' reports for accuracy
- Trained new associates
- Presented case reports at departmental meetings
- Served as backup for team leader
Candidate Info
Associate of Applied Science
Adult Learning (graduate Certificate)
Biotechnology (ms)
Medical And Research Technology (bs)
Biology (bs)
Drug Safety Associate
- Performed triage and assigned priority to incoming events and classified them according to regulatory reporting criteria
- Evaluated cases for seriousness, relatedness and expectations according to the protocol, investigator brochure and/or package insert
- Ensured compliance with GCP guidelines, FDA Code of Federal Regulations and ICH Standards
- Received incoming call reporting serious and non-serious missing adverse event information
- Reviewed adverse events and source documentation for accuracy, integrity, and consistency per project specific guideline
- Interacted with project team members to ensure correct and timely adverse event follow-up and case closure
- Maintained a thorough understanding of the protocol and scope of work for assigned projects
Candidate Info
Management (mba)
Drug Safety Associate
Supported Worldwide Drug Safety Surveillance activities for marketed and investigational products
- Provided signaling input to Team Leader for transmission to Medical Services
- Assessment and follow-up of adverse events based on regulatory requirements
- Prepared necessary reports for transmission to Schering-Plough subsidiaries, licensees and health authorities
Candidate Info
Applied Science)
Drug Safety Associate (dsa)
Participated in review of GPV Open Report Project (GPVORP)
- GPVORP Team assessed approximately 5,000 SAE reports for accuracy, legibility, and completeness for seriousness and expectedness/listedness
- Processed clinical trial SAE and AE reports per company SOPs including the drafting of initial and follow-up narratives
- Obtained follow-up SAE information from clinical sites and CROs including responses to outstanding queries for clinical trial reports
- Interacted with company physicians on a one on one basis for assistance with SAE term upgrading when needed
- Attended weekly scheduled staff meetings
- Participated in appropriate training pertinent to job performance
Candidate Info
Zoology (bs)
Drug Safety Associate
- Responsibities for collection, evaluation, initial assessment, and timely submission of adverse experience reports relate to company marketed and investigational drug products.
- Determined the appropriate regulatory reporting requirements in accordance with the global regulations and guidelines (Sanofi's SOPs, FDA regulations, and ICH guidelines).
- Conducted clinical assessment and process information on reported adverse events and serious adverse events in the safety database.
- Ensured timely entry of adverse events reports in the access database; entered medical information i.e. medical history, laboratory test results and risk factors.
- Generated and reviewed individual adverse event reports, tabulations and data summaries.
- Assisted with protocols, informed consent, amendments and investigator brochures and study report.
- Prepared updated Dear Investigator Letter with each regulatory document for all protocols and for each site initiated.
- Expedited the MedWatch/CIOMs reports forms reviewed the reports for accuracy and completeness.
Candidate Info
years in workforce
months at this job
Bachelor of Science in Nursing
Master of Arts
Sr. Drug Safety Associate
Processing, collection and follow-up on post-marketing spontaneous and solicited adverse event reports for submission within ICH and local authority requirements.
- Performance of risk and quality functions on AE reports, including manual coding, as needed.
- Prioritize workload for products and liaise with Safety Associates and others involved in workflow to ensure timely
- Production and review of periodic annual reports for post-marketing surveillance.
- CoTherix was acquired by Actelion, Inc in January 2007.
Candidate Info
years in workforce
months at this job
Design
Education
Drug Safety Associate
Maintain accurate and thorough documentation in order to ensure good audit practice in compliance with GCP, GMP, ICH, Federal US and any pertinent local regulations.
- Conduct quality reviews of non-serious cases in order to ensure quality and consistency of information.
- Performed Duplicate Searches, Triage, Registry and Case Processing of serious and non-serious adverse event reports adhering to Standard Operating Procedures
- Triage review and follow-up assessment of safety case reports of ICSRs determine seriousness and assess causality.
- Assist with conducting final Medical Review of ICSRs.
- Case assessment and processing in the electronic database according to established department convention
- Ensure compliance with regulatory timelines for individual expedited case reports submissions and timely delivery of information for aggregate reports and other regulatory documents as requested.
- Complete timely diligence, review and processing of adverse event reports as requested in order to fulfill all regulatory reporting obligations.
- Has maintained functional and project management responsibilities surrounding serious adverse event reporting, narrative writing, safety database reconciliation (Oracle AERS, ARGUS and ARISg), E2B safety data migration and trained in signal detection, risk management and global regulatory reporting.
- Coordinated trials in an academic setting and directed all regulatory and safety aspects of these clinical studies including submissions of ADR and SAE reports and annual reports to the IRB, and FDA.
Candidate Info
years in workforce
months at this job
Design
Education
Drug Safety Associate
Maintain accurate and thorough documentation in order to ensure good audit practice in compliance with GCP, GMP, ICH, Federal US and any pertinent local regulations.
- Conduct quality reviews of non-serious cases in order to ensure quality and consistency of information.
- Performed Duplicate Searches, Triage, Registry and Case Processing of serious and non-serious adverse event reports adhering to Standard Operating Procedures
- Triage review and follow-up assessment of safety case reports of ICSRs determine seriousness and assess causality.
- Assist with conducting final Medical Review of ICSRs.
- Case assessment and processing in the electronic database according to established department convention
- Ensure compliance with regulatory timelines for individual expedited case reports submissions and timely delivery of information for aggregate reports and other regulatory documents as requested.
- Complete timely diligence, review and processing of adverse event reports as requested in order to fulfill all regulatory reporting obligations.
- Has maintained functional and project management responsibilities surrounding serious adverse event reporting, narrative writing, safety database reconciliation (Oracle AERS, ARGUS and ARISg), E2B safety data migration and trained in signal detection, risk management and global regulatory reporting.
- Coordinated trials in an academic setting and directed all regulatory and safety aspects of these clinical studies including submissions of ADR and SAE reports and annual reports to the IRB, and FDA.
Candidate Info
years in workforce
months at this job
Physical Therapy
Sports And Fitness Management
Drug Safety Associate
Maintain accurate and thorough documentation in order to ensure good audit practice in compliance with GCP, GMP, ICH, Federal US and any pertinent local regulations.
- Conduct quality reviews of non-serious cases in order to ensure quality and consistency of information.
- Performed Duplicate Searches, Triage, Registry and Case Processing of serious and non-serious adverse event reports adhering to Standard Operating Procedures
- Triage review and follow-up assessment of safety case reports of ICSRs determine seriousness and assess causality.
- Assist with conducting final Medical Review of ICSRs.
- Case assessment and processing in the electronic database according to established department convention
- Ensure compliance with regulatory timelines for individual expedited case reports submissions and timely delivery of information for aggregate reports and other regulatory documents as requested.
- Complete timely diligence, review and processing of adverse event reports as requested in order to fulfill all regulatory reporting obligations.
- Has maintained functional and project management responsibilities surrounding serious adverse event reporting, narrative writing, safety database reconciliation (Oracle AERS, ARGUS and ARISg), E2B safety data migration and trained in signal detection, risk management and global regulatory reporting.
- Coordinated trials in an academic setting and directed all regulatory and safety aspects of these clinical studies including submissions of ADR and SAE reports and annual reports to the IRB, and FDA.
Candidate Info
Nursing (bs)
Medical Technology, Ascp (bs)
Drug Safety Associate
Received, tracked and processed post-marketing SAE reports per SOPs
- Independent review and analysis of complex medical records, line listings and legal documents
- Documented, coded and entered information on SAES into safety database and wrote and submitted patient narratives (summaries) to pharmaceutical company sponsor and FDA within required time frames per ICH and GCP guidelines
- MedDRA and WHODrug coding and data entry into a validated safety database
- Raised and tracked queries
- Team lead and quality control reviewer of processed cases and narratives and assisted in training of junior DSAs
Candidate Info
Chemistry (ma)
Organic Chemistry (ms)
Biology (bs)
Senior Drug Safety Associate
- Provided AERS safety database training to new drug safety employees
- Created data entry manual for new AERS database users
- Participated in AERS validation and change of control processes and assisted in system enhancement efforts
- Provided constant support to drug safety end users in resolving day-to-day AERS operation issues
- Processed adverse events/SAE reports associated with post-marketed and investigational [company name] products
- Wrote narrative summaries for spontaneous and clinical serious adverse events reports
- Quality reviewed electronic migration of clinical cases to Biogen-Idec's AERS database
Candidate Info
Drug Safety Associate
- Responded to on-label and off-label medical information inquiries from consumers and healthcare professionals
- Received, documented and triaged adverse event reports received via phone, email, fax, and postal mail
- Performed final review of adverse event reports in pharmacovigilance database
- Created standard operating procedures, guidelines and training documents for medical information computer systems
Candidate Info
Drug Safety Track Certification From Temple University School Of Pharmacy
Medical Affairs, Drug Safety Associate/consultant
- Triaged large volume of source documents (litigation memos, fact sheets, medical records, diagnostic findings) to identify AEs
- Determined seriousness criteria for newly identified AEs as defined by the FDA utilizing sponsor-specific medically significant events list
- Determined reporting requirements to the sponsor and regulatory authorities
- Performed coding activities utilizing MedDRA dictionary for AEs, disease states, and diagnostic procedures
- Wrote initial and follow-up safety narratives
Candidate Info
Dental Medicine (doctorate)
Clinical (bs)
Senior Drug Safety Associate
Performed duties of Sr. DSA working in clinical drug safety role, including QA/QC of drug safety coordinators, performing signal detection, triage of serious adverse event reports by listedness and relatedness, direct communication with Sr. CRO's, submission of 7- and 15-day expedited SAE's, comprehensive narrative writing and quality control for an ESA Phase 3 medication indicated for anemia with monitoring of cardiovascular composite safety endpoints and reconciliation to safety database.
- Expert in all aspects of MedDRA coding and QA/QC for drug safety coordinators
- Therapeutic area specialties: Nephrology and Cardiovascular
- Expert in ARGUS, Clintrace, Scopus drug safety databases. Proficient in ArisG database.
- Performed reconciliation of SAE's with drug safety and clinical trial databases with changes made in conjunction with regulatory compliance.
- Monitoring of composite safety endpoints and signals with data reconciliation to safety database.
Candidate Info
years in workforce
months at this job
Nursing
Drug Safety Associate
Triage of incoming adverse event reports for completeness, legibility, and validity.
- Assess events appropriately for seriousness, causality and expectedness, and follow up with sites and sponsors for FDA required information.
- Responsible for adverse event, drug coding and writing case narratives.
- Assist Medical Directors with medical monitoring activities including collection and review of endpoint packages, patient eligibility issues, protocol violations, and review of study specific Model Informed Consent Forms.
- Work within teams of Medical Directors/Safety Physicians, Medical Project Managers, sponsors, Principal Investigators and their site staff.
- Participate in internal and external team meetings and project specific training sessions.