Reporting to the Global Head Drug Safety and Pharmacovigilance, the Drug Safety Physician is responsible for the medical assessment of Individual Case Safety Reports (ICSRs) and other drug safety information. The individual will be responsible for assessing, surveilling and interpreting safety data from multiple sources, including clinical trials, spontaneous and solicted reports, aggregate and literature reports. This physician is expected to provide interpretation and summaries of drug safety information, and provide input in the generation of safety reports (e.g. DSURs, PSURs, clinical safety assessments). The individual will be an integral part of a group of safety professionals, and will closely collaborate with safety teams in Contract Research Organizations (CROs). He/she will need to maintain medical knowledge as required by the role, strong and current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, and surveillance and risk-management practices.
Essential Functions and Duties
- Provide medical expertise in the assessment of ICSRs and aggregate drug safety reports.
- Review, analyze, and compile safety data, and present the results
- Contribute to the generation of aggregate safety reports including periodic/development safety update reports, periodic benefit risk evaluation reports, and provide medical input for review of new or existing safety documents that ensure compliance with relevant regulatory requirements, such as protocols, safety summaries and regulatory reports.
- Support of the internal PV Operations (case processing) function.
- Contribute to ongoing safety surveillance and signal detection efforts.
- Contribute to the identification, assessment and communication of potential safety signals.
- Service as a medical resource for the generation and review of clinical trial protocols, and investigator brochures.
- Provide medical safety input into the development of Reference Safety Information.
- Contribute to Risk Management Plans (RMPs) and/or Risk. Evaluation and Mitigation Strategies (REMS) for assigned products, and the maintenance of these documents.
- Provide medical safety and Pharmacovigilance (PVG) expertise in-house and by consultation with outside vendors for all development programs.
- Contribute to the development of Standard Operating Procedures, Working Instructions and other guidance documents.
- Contribute to safety and pharmacovigilance training programs.
- Provide safety training at investigator meetings.
- Present safety data and results.
- Collaborate with Regulatory Affairs to ensure appropriate reporting of PVG and drug safety information to regulatory agencies and prescriber community.
- Collaborate with Medical Directors and Clinical Research Scientists, and vendor clinical staff who provide medical monitoring support for ongoing clinical trials.
- Develop relationships with and capture drug safety information from key groups, including partner companies, physicians, nurses and patient advocacy groups.
- Serve as a subject matter expert for vendors providing drug safety and pharmacovigilance services.
Skills and Experience
- 6+ years’ experience in Drug Safety / Pharmacovigilance in a pharmaceutical or biotech company, CRO or regulatory agency.
- Medical Degree (MD) from a recognized medical school with at least 4 years of medical practice.
- Good working knowledge of US and EU drug safety regulations, CIOMS and ICH guidelines.
- Demonstrated exposure to medical drug safety assessments, drug safety surveillance and monitoring activities.
- Experience with medical review of ICSRs, including expectedness assessments, causality assessments, narrative review and generation, generation of Analysis of Similar Event summary statements.
- Experience with safety data collection and interpretation originating from clinical trials.
- Experience with the medical review of aggregate reports.
- Experience with the review of Reference Safety Information for drug safety purposes.
- Ability to build relationships and influence across disciplines.
- Experience with data entry, MedDRA or similar coding and safety database systems.
- Excellent verbal, written and presentation skills.