Executive - Regulatory Affairs & Pharmacovigilance

Ferring India M&S

India
Not specified
Safety information reporting
Safety mailbox review
Monthly reconciliation and compliance
Ferring India M&S is seeking an Executive for Regulatory Affairs & Pharmacovigilance, responsible for safety reporting and regulatory submissions in the pharmaceutical sector. The ideal candidate should have at least one year of relevant experience and a background in pharmacy or life sciences

Job Summary

  • The key activities include reporting of safety information from India & India cluster to the Global Safety Follow up for additional information with the reporters.
  • 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.
  • Contribute in preparation for regulatory authority meetings and expert committee meetings, preparation of dossiers for regulatory submissions and followups for South Asia countries.

Matching Summary

Match Score: 75

Ferring India M&S is seeking an Executive for Regulatory Affairs & Pharmacovigilance, responsible for safety reporting and regulatory submissions in the pharmaceutical sector. The ideal candidate should have at least one year of relevant experience and a background in pharmacy or life sciences.

Skills & Requirements

Must-have

  • Safety information reporting
  • Safety mailbox review
  • Monthly reconciliation and compliance
  • Periodic Safety Update Reports
  • Dossier preparation for submissions
  • Promotional material review

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

Tailored Resume

Cover Letter