Executive - Regulatory Affairs & Pharmacovigilance

ferring.de

India
**
Safety information reporting
Periodic safety update reports
Dossier preparation for submissions
** Ferring Pharmaceutical is seeking an Executive for Regulatory Affairs & Pharmacovigilance in India, responsible for safety report management, regulatory submissions, and compliance checks. The ideal candidate should have over a year of experience in regulatory affairs within the pharmaceutical or biotech industry, along with a relevant educational background. **

Job Summary

  • Reporting of safety information from India & India cluster to Global Safety.
  • Gathering requirements and preparation of dossiers for submission to the Indian regulatory authority for new products, clinical trials, variations, and renewals.
  • Coordination and checks for price updates and entry of information timely into the Pricing Authority database (NPPA).

Matching Summary

Match Score: 75

** Ferring Pharmaceutical is seeking an Executive for Regulatory Affairs & Pharmacovigilance in India, responsible for safety report management, regulatory submissions, and compliance checks. The ideal candidate should have over a year of experience in regulatory affairs within the pharmaceutical or biotech industry, along with a relevant educational background. **

Skills & Requirements

Must-have

  • Safety information reporting
  • Periodic Safety Update Reports
  • Dossier preparation for submissions
  • Promotional material review
  • Regulatory Databases updation

Nice-to-have

  • Coordination with global teams
  • Lifecycle maintenance
  • Timely information updates

Key Requirements

  • 1+ years experience
  • India Regulatory Affairs
  • Pharmacovigilance functions
  • Pharma or Biotech Industry

Work Rights

Not specified

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