Senior Manager Country Safety Lead - India
Core
Establishing and managing end-to-end Pharmacovigilance (PV) operations and compliance for Biogen's new India entity, serving as the local Pharmacovigilance Officer in Charge (PVOIC) and strategic partner to global functions.
Role type
Senior Manager, Pharmacovigilance Lead (PVOIC)
Builds
Local PV structure, processes, and compliance systems for post-marketing safety in India
Domain
Pharmaceutical industry, Pharmacovigilance, Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmacovigilance operations management, regulatory compliance (local & global), vendor management, audit and inspection coordination, SOP development, training delivery, risk management planning
Preferred skills
GxP compliant quality systems, Adverse Events Intake systems, writing procedures and training materials, experience with audits and regulatory inspections
Technologies
Adverse Events Intake systems, Pharmacovigilance System Master File (PSMF), Risk Management Plans (RMPs)
Responsibilities
Establish and maintain local/regional PV structure and practices in compliance with local regulations; manage receipt, collection, and submission of Individual Case Safety Reports (ICSRs); oversee Health Authority submission compliance for Aggregate Reports; manage local signal management processes; recruit, onboard, and oversee PV operations vendors and third parties; lead local Finance and IPV on budget and resource planning; author local PV documents (SOPs, Guidelines, Safety Management Plans); maintain local Pharmacovigilance System Master File (PSMF); act as lead contact for local Pre and Post-Marketing inspections and audits; contribute to global PV strategy and regulatory intelligence infrastructure; manage local safety staff and resources.
Seniority
Senior Manager, hands-on leadership
