Description
- Responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.
- Support Medical Safety Assessment Physicians (MSAP) in leading Safety Data Review (SDR) Teams.
- Appropriately perform core signal detection activities and elevate program or portfolio issues impacting key MST programs, priorities, resources, and milestones with appropriate oversight.
- Author responses for safety data queries and contribute to specified PV sections of the Periodic Benefit Risk Evaluation Report (PBRER) and Development Safety Update Report (DSUR).
- Ensure pharmacovigilance regulatory compliance with oversight
- Lead Safety Data Review (SDR) Teams and participate in related PV and product-development subteam(s).
- Appropriately elevate signal detection findings impacting key MST activities, milestones,



and documents to the MST Chair.
- Support individuals in aspects of project management, drug development and MST requirements, as appropriate to meet overall MST/subteam needs.
- Author and contribute to specified PV sections of the PBRERs and DSURs with oversight
- Author responses to safety data queries from health authorities including coordination and integration of scientific, medical, and regulatory input from a variety of scientific sources and functional groups, to support responses to safety data/ad hoc queries and HA requests.
- Perform periodic review and summary of pertinent safety related literature and analysis of pre-determined core signal data.
- Collaborate within and across company functions with appropriate disciplines to identify and ensure management of internal and external documentation and support when required.
- Share with individuals and teams on these applied learning's.

Sal

📌 Pharmacovigilance Scientist (Wagholi)
🏢 Statistical Pharma
📍 Wagholi