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Drug Safety Specialist Resume Samples
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0-5 years of experience
Received adverse events and review for potential patient risk and severity to determine if the reportable nature of event.
- Responsible for collecting information and updating/opening complaint files in the Complaint Management Database
- Interface with customer service, health care professionals, caregivers, and patients to gather additional information required for complaint investigations and adverse drug experience (ADE) reporting.
- Responsible for the completion and submittal of ADE reports.
- Review complaints for a potential FAR and prepare an NDA field alert report to submit to the FDA in accordance with regulations
- Maintain current knowledge of the FDA Quality System and FDA regulations for medical device and adverse drug experience reporting (21 CFR part 803, 829, 211, 312, and 314)
- Manage workflow to ensure timely ADE reporting, customer follow up, and closure of complaints in compliance within FDA and corporate guidelines
0-5 years of experience
Managed the triage of safety reports received into central Drug Safety inbox.
- Assisted in the preparation of NDA Safety Updates, IND safety reports, investigator communications, and other reports as necessary.
- Responsible for the initial assessment of causality and reportablity of an SAE report.
- Assisted in the creation or revision of Drug Safety SOPs and Work Instructions.
- Determined critical queries for missing, discrepant, or additional source document needed for safety reports.
- Improved the SAE reconciliation process to be more efficient. Coordinated with Data Management personnel to reconcile key data fields between the Safety Database and the Clinical database; assisted in rectifying any discrepancies.
- Lead trainer for workflow process in Argus Safety Databases for new hires.
- Data entered relevant SAE information of a safety report into the Argus Safety Database.
- Collaborated with partnered CROs and Regulatory Affairs department to collect, compile, and check the compliance percentage of previous Safety Reports submissions to the regulatory authorities
0-5 years of experience
- Completed data entry of individual case safety reports (ICSRs) from clinical trials and post marketing sources utilizing ARGUS. Also performs active follow-up on ICSRs
- Conduct complete clinical reviews of all domestic and foreign adverse event reports for all Acorda investigational and marketed products
- Ensured consistency in the evaluation and assessment of adverse event reports and source documentation for completeness, accuracy and legibility and ensured compliance with the Safety Data Exchange Agreement (SDEA) was fulfilled
- Exercised judgment and use of knowledge of FDA and ICH guidelines and product labeling in performing initial case assessment for seriousness, expectedness, causality, listedness and reporting requirements
0-5 years of experience
- Responsible for reviewing and managing all Adverse Event and Product Quality Complaint reports and associated documentation to ensure they have been accurately assessed. Used Track- it to track and assure global adverse event forms were properly submitted to FDA.
- Assist, review and analyze Product Quality Complaints and Adverse events reported in result of the 2010 Tylenol recall.
- Review and analyze AE and PQC narratives, and submit claims to FDA if necessary. Track AE and PQC reports and ensure they are submitted within the specific timelines per FDA/ company/client Standard Operating Procedures.
- Responsible for managing, evaluating global quality complaints, documenting and providing AE and PQC related training feedback to registered nursing call center staff.
- Evaluating product quality complaints for seriousness or non-serious, creating and reviewing standard operating procedures.
- Work as a team member on improving processes, procedures and ad hoc projects for the Quality Control Department. Determined whether an Adverse Event is serious or non-serious and Interpretation of drugs and disease terms. Utilized systems such as Argus, Medra, Track it, QMS and MediTech to complete various positions
0-5 years of experience
- Review and process ICSRs of adverse events obtained from various sources including spontaneous, clinical trials accurately to determine regulatory reporting requirements and ensure quality data
- Perform triage of cases and determine seriousness and relatedness across products as assigned and assessed all clinical study cases for SUSAR identification.
- Perform data entry of identified adverse event information accurately into Safety Database after performing duplicate search
- Also perform Quality review of the data entered, coding, narrative to ensure accuracy and compliance
- Processed cases with an accuracy and consistency at various stages of the system workflow
- Generate queries and work with other team members to send follow-up letter/queries to the appropriate reporter, forwarding to clinical sites where appropriate
- Ensure timely submission of expedited reports to Regulatory Authorities by adhering to the company SOPs, national and international regulations
- Conduct training, update team members and new drug safety coordinator about standard company workflow, activities and modification in the SOPs
- Assist in Quality Assurance-Identify and report any compliance gaps related to the full Quality System Regulation. Interact with multiple levels of staff within the PV department to report quality issues and gain resolution.
- Liaised with different functional team members, including project management, clinical data management, site coordinators, investigators, medical monitors, and designees to address project related issues.
0-5 years of experience
- I am currently processing adverse events (AEs) and serious adverse events (SAEs) reports for marketed products and investigational compounds. I am responsible for coordinating investigations with Quality Assurance, entering time-bound patient case data to safety surveillance, preparing SAE narratives and safety follow-up assessments, and generating IND Safety Reports following FDA guidelines.
- I routinely perform quality checks on safety assessments, safety reviews, and safety reports to be certain that all required elements are captured and follow FDA guidelines.
- I work with individuals across various functional units such as the Regulatory Medicine team and Clinical Quality Assurance aligned with the interface of pharmacovigilance and safety surveillance processes.
- I am active in providing input into SOPs, updates, and modifications to initiate appropriate changes as well as providing input on end-user issue with safety databases.
- I review and verify AE and concomitant medication coding via MedDRA and WHO Drug coding internally referencing package inserts and investigational brochures.
- I evaluate and process Expected Adverse Event (EAE) reports received from clinical sites including preparation of Safety Reports as per project and regulatory guidelines. I independently review experimental protocols and safety information from the Division of AIDS (DAIDS) studies.
- I analyze medical research data and then summarize safety data into chronological, well thought out, and detailed case narratives.
- I collect accurate information from the site and enter necessary information into the Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Event Reporting System (DAERS). Respond to e-mail or phone queries from on case specific issues. Participate in the development of project specific procedures (PSPs), Project Work Instructions (PWIs), standard operating procedures (SOPs). Work on ad-hoc safety projects as necessary and appropriate.
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[Drug Safety Specialist]
Last edited by: Gabriela Barcenas, CPRW, Content Writer II -
Gabriela Barcenas
CPRW, Content Writer IIGabriela is a Certified Professional Resume Writer (CPRW) and career adviser. With 10 years of digital media experience and five years of resume writing expertise, her publication history includes fashion, education, travel, social justice, equitable design and career advice.
