Executive - Regulatory Affairs & Pharmacovigilance

Ferring India M&S

India
Not specified (assumed to be office-based in india).
Reporting safety information
Safety mailbox review
Periodic safety update reports
Ferring India M&S is seeking an Executive in Regulatory Affairs & Pharmacovigilance to manage safety reporting and regulatory submissions for pharmaceutical products across South Asia. The ideal candidate will have a background in pharmacy or life sciences, along with relevant experience in regulatory affairs and pharmacovigilance

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.
  • Timely information for updation of Regulatory Databases, updation of local SOPs, and updation / renewal of Safety Agreements for Partners, Manufacturers, Distributors.

Matching Summary

Match Score: 85

Ferring India M&S is seeking an Executive in Regulatory Affairs & Pharmacovigilance to manage safety reporting and regulatory submissions for pharmaceutical products across South Asia. The ideal candidate will have a background in pharmacy or life sciences, along with relevant experience in regulatory affairs and pharmacovigilance.

Skills & Requirements

Must-have

  • Reporting safety information
  • Safety mailbox review
  • Periodic Safety Update Reports
  • Dossier preparation for submissions
  • Promotional material review
  • Local SOP updation

Nice-to-have

  • Coordination with global teams
  • Contribution to authority meetings
  • Lifecycle maintenance updates

Key Requirements

  • 1+ years experience
  • India Regulatory Affairs
  • Pharmacovigilance functions
  • Pharma or Biotech Industry
  • Bachelors in Pharmacy or Lifesciences

Work Rights

Not specified

Tailored Resume

Cover Letter