Job Description
Lead Safety Surveillance, Risk Management, Pharmacovigilance

We are seeking an exceptional leader to lead the Safety Surveillance, Risk Management in Biocon Biologics Pharmacovigilance. Reporting to the Head, Pharmacovigilance, the person is responsible for adverse event monitoring, safety signal management activities, risk management plans, overseeing the aggregate report scheduling, preparation, and submission, responding to safety questions from internal and external stakeholders, overseeing the medical and scientific literature review for safety information, vendor medical oversight for ICSR medical review and supporting clinical trial PV safety activities. Along with the team of Drug Safety Physicians and Drug Safety Specialists the lead Safety Surveillance, Risk management will be responsible for continuous evaluation of the safety profile of company products. The right candidate will have leadership skills, be an excellent communicator with an ability to have oversight over CRO activities,



monitor safety compliance and can successfully lead and influence external and internal stakeholders. Lead Safety Surveillance and Risk Management also serve as a subject matter expert for drug safety, cross functional teams, and vendors on relevant global safety regulations and guidelines, data output & analyses, and product-specific safety information.

Responsibilities:
• Contributes to the development & maintenance of product safety profile.
• Involved in all safety surveillance activities, which may include monitoring adverse events and all other safety information to manage the safety profile of the company products
• Monitors the signal management process (i.e. set up process for periodic signal detection for company products, signal tracking, review meetings, signal detection overview reports, eRMR reports, etc) for the company product (s) and evaluates safety data and signals as part of ongoing pharmacovigilance activities.
• Collaborates with exte

📌 Lead Safety Surveillance (Bengaluru)
🏢 BIOCON BIOLOGICS
📍 Bengaluru