The Pharmacovigilance (PV) Science Expert is a global role, and it supports an international, energetic, and culturally diverse team dedicated to safety surveillance throughout the product lifecycle of a broad range of products.
The PV Science Expert is a safety expert who is responsible for performing core pharmacovigilance activities on a product, in partnership with the Global Safety Lead/Managers (GSLs/GSMs), to identify safety signals, evaluate, and analyze safety data for both marketed products and products in post marketing and clinical development.
Accountabilities :
- Manages ongoing core signal detection activities for Global Safety Leads/Managers (GSLs/GSMs) review (involve synthesis of data from multiple sources: PV database, literature, PV textbooks and external DBs)
- Coordinates and authors draft health hazard evaluations (HHEs) and/or safety evaluation reports (SERs)
- Primarily manages entry and tracking of signals, ME, INR in SMART tool and support GSLs/GSMs with any SMART related activities.
- Reviews periodic signal detection reports (NINR, UDR,



SD reports for PBRERs)
- Contributes to responses to Health Authority questions or inquiries from internal or external stakeholders in collaboration with the Safety Team; includes proposing a strategy for the response review of relevant data.
- Is a Core member of the Safety Management Committee (SMC) who contributes to produce the necessary data outputs, prepares slide presentations.
- Supports GSL/GSM to provide safety content for new drug applications and other regulatory filings including review of the safety and benefit risk sections to ensure consistency across documents and support response preparation
- Supports GSL/GSM in drafting of the safety sections of the EU Risk Management Plan (RMPs) for Safety Team for review and comment.
- Contributes to risk assessment and benefit risk assessment for marketed products (Scheduling and coordinating meetings/ Drafting meeting agenda and minutes/Tracking acti

📌 Pharmacovigilance Science Expert (Secunderabad)
🏢 Sanofi
📍 Secunderabad