The Pharmacovigilance (PV) Drug Safety Physician provides expert medical safety analysis for periodic safety aggregate reports (e.g., DSUR, PSUR/PBRER, ACO, RMP, PADER, bridging reports, signal reports, literature articles, health authority requests/queries and other relevant aggregate reports for pharmaceutical products and biologics/biosimilars).
The PV Drug Safety Physician should be able to perform medical review of all types of individual case safety reports (ICSRs) by writing an expert company pharmacovigilance comment. The PV Drug Safety Physician maintains distinctive quality and commitment as the operating philosophy in carrying out all processes and continually seeks out ways to enhance medical expertise in team both internally and externally.
- Provides medical review of safety events (pre-marketing, post-marketing, device, and drug) and/or other medically related information per assigned tasks and project-specific procedures.
- Provides input and review relevant safety information for signal detection and risk management activities.
- Performs safety review of clinical and diagnostic data as part of case processing and aggregate reporting.
- Provide medical review of aggregate reports (e.g., PSUR, PBRER, DSUR, and ASR).
- Literature and medical review of the literature search strategy.
- Serves as the main pharmacovigilance/safety physician point of contact for the customer for the life cycle of assigned projects.
- Is a member of the signal management committee.
- Assists with identifying out of scope activities in conjunction with the PV Project lead (as applicable).
- Attends project team and client meetings (including Investigator meetings) and teleconferences as required.
- Participates in Business Development activities as requested.
- Performs other activities as identified and requested by management.
- Provides input and consultancy to the client in the course of generation of the Company Core Data Sheet/Core Safety Information and Product Information.
- Provides guidance to Pharmacovigilance and Safety Services staff with regards to the regulatory reporting of adverse events.
- Assists with generation of project specific procedures (medical review workflow activities).
- Supports QPPV and management as required.
- Must regularly liaise with peer medical reviewers and also with vendor medical reviewers in assessing expert outcomes or opinions for all Safety reports.
- Provides training on medically relevant topics, as and when required.
- Providing oversight for overall PV and medical science for relevant medical products.
- Other duties as assigned.
