1
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
Nursing (bsn)
2
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
C
Certificate
Retail & Customer Service Training Program
Medical Assistant (diploma)
Business
Management Training
3
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
BS
Bachelor of Science
BA
Bachelor of Arts
4
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
1
year in
workforce
workforce
1
year
at this job
at this job
AS
Science
BA
Psychology
Nursing
5
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
8
years in
workforce
workforce
11
months
at this job
at this job
C
Gcp / Ich
C
Certificate
6
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
MBA
Master of Business Administration
Pharmaceutical Sciences (bachelors)
7
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
Pharmacy
Music
8
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
2
years in
workforce
workforce
1
year
at this job
at this job
AAS
Nursing
BS
Ceramic Science And Engineering
MS
Polymer Science
9
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
12
years in
workforce
workforce
5
years
at this job
at this job
BS
Nursing
10
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
C
Certificate
Nursing (vocational)