Job Description

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&S

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