Manager / Senior Manager Pharmacovigilance

Roles & Responsibilities
• Support and manage local Pharmacovigilance operations in India
• Act as Deputy Pharmacovigilance Officer-in-Charge (PVOIC)
• Assist Local PV Responsible Person in meeting regulatory and compliance obligations
• Oversee end-to-end ICSR management including intake, processing, review, and submission
• Conduct literature surveillance and ensure timely safety reporting
• Maintain and update Pharmacovigilance System Master File (PSMF)
• Oversee safety reporting for marketed products, clinical studies, and special programs
• Ensure compliance with local and global PV regulations
• Support preparation and submission of PSUR/PBRER
• Implement and maintain Risk Management Plans (RMPs)
• Contribute to signal detection, evaluation, and escalation activities

Qualification
• M.Pharm / Pharm.D / MBBS / Life Sciences (relevant qualification preferred)

Experience
• 5+ years of Pharmacovigilance experience
• Strong experience in India PV regulations (mandatory)
• Experience in local PV operations and regulatory compliance

Skills
• Strong knowledge of Indian and global PV regulations
• Expertise in ICSR lifecycle management and literature review
• Hands-on experience in PSMF maintenance and RMP implementation
• Experience in PSUR/PBRER preparation and submission
• Signal detection and risk evaluation skills
• Strong leadership and stakeholder coordination abilities
• Excellent documentation and communication skills

About the Company
Domnic Lewis has been mandated by a Global Pharmaceutical MNC to recruit for this strategic Pharmacovigilance leadership role. The organization operates in highly regulated markets and emphasizes strong compliance, patient safety, and regulatory excellence while offering growth opportunities in local and global PV operations.