Roles & Responsibilities:
• Report safety information from India and India cluster (South Asia countries) to Global Safety
• Follow up with reporters for additional safety information
• Review and manage safety mailbox for incoming reports
• Perform monthly reconciliation and compliance checks from a pharmacovigilance perspective
• Prepare and submit Periodic Safety Update Reports (PSURs) to regulatory authorities as per regulations
• Gather requirements and prepare regulatory dossiers for new products, clinical trials, variations, and renewals
• Prepare responses to regulatory authority queries and coordinate with global teams
• Support preparation for regulatory authority and expert committee meetings
• Prepare and follow up on regulatory submissions for South Asia countries
• Prepare and update product labeling materials
• Review promotional materials for compliance with approved product registrations
• Ensure timely updates to regulatory databases
• Update and maintain local SOPs
• Update and renew safety agreements with partners, manufacturers, and distributors
• Coordinate price updates and ensure timely entry into NPPA pricing database
• Manage lifecycle maintenance activities and update commercial teams on key milestones
Qualifications:
• Bachelor’s degree in Pharmacy, Life Sciences, Microbiology, Chemistry, or related field
Experience:
• Minimum 1+ year experience in India Regulatory Affairs and Pharmacovigilance
• Experience within pharmaceutical or biotechnology industry preferred
Skills:
• Knowledge of Indian regulatory and pharmacovigilance requirements
• Strong documentation and dossier preparation skills
• Ability to coordinate with global and cross-functional teams
• Good communication and regulatory compliance understanding
• Attention to detail and ability to manage multiple submissions
About the Organization:
Ferring Therapeutics is a global, research-driven biopharmaceutical company committed to developing innovative treatments in areas of high unmet medical need. The company focuses on maintaining the highest standards of quality, regulatory compliance, and patient safety while delivering life-changing therapies worldwide.
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