The role involves reporting safety information, preparing regulatory submissions, updating databases, and ensuring compliance with local regulations.
Job Description:
The key activities include:
- Reporting of safety information from India & India cluster (South Asia countries) to the Global Safety
- Follow up for additional information with the reporters
- Review safety mailbox for the reports
- Monthly Reconciliation and Compliance checks from PV perspective
- Submission of Periodic Safety Update Reports to the regulatory authority as per regulations
- Gathering the requirements and Preparation of dossiers for submission to the Indian regulatory authority for new products, clinical trials, variations, renewals of registration certificates, etc. , preparation for query responses to the authority, coordination with the global teams
- Contribute in preparation for regulatory authority meetings and expert committee meetings
- Preparation of dossiers for regulatory submissions and followups for South Asia countries
- Preparation and updation of labeling materials for our products
- Promotional material review in compliance with product registrations
- Timely information for updation of Regulatory Databases
- Updation of local SOPs
- Updation / renewal of Safety Agreements for Partners, Manufacturers, Distributors
- Coordination and checks for price updates and entry of information timely into the Pricing Authority database (NPPA)
- Lifecycle maintenance, and update commercial team in a timely manner of major milestones
Qualification: Bachelors in Pharmacy or Lifesciences or Microbiology, Chemistry, or similar
Experience: 1 + years in India Regulatory Affairs and Pharmacovigilance functions in Pharma or Biotech Industry
Location:Ferring India M&STop Skills
Regulatory Databases
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