• Report safety information from India & South Asia cluster to Global Safety
• Perform follow-ups with reporters for additional safety information
• Monitor and review Pharmacovigilance safety mailbox
• Conduct monthly PV reconciliation and compliance checks
• Prepare and submit Periodic Safety Update Reports (PSURs) as per regulations
• Prepare regulatory dossiers for new products, clinical trials, variations, renewals, and query responses
• Coordinate with global teams for regulatory submissions and approvals
• Support regulatory authority and expert committee meetings
• Prepare and maintain regulatory submissions for South Asia countries
• Update and maintain product labeling and promotional material compliance
• Ensure timely updates in regulatory and pricing databases (NPPA)
• Update and maintain local SOPs and Safety Agreements
• Support lifecycle management and inform commercial teams on key milestones
• Bachelor’s degree in Pharmacy
• OR Life Sciences / Microbiology / Chemistry or related discipline
• Minimum 1+ year experience in Regulatory Affairs and Pharmacovigilance
• Experience in Indian pharma or biotech industry preferred
• Strong knowledge of Indian regulatory and PV requirements
• Familiarity with PSURs, safety reporting, and compliance processes
• Good coordination and communication skills
• Attention to detail and documentation accuracy
• Ability to work cross-functionally with global teams
• Ferring India M&S is part of the global Ferring Pharmaceuticals group, Focused on research-driven, specialty biopharmaceutical products
Unlock refined AI insights.