Executive - Regulatory Affairs & Pharmacovigilance

Ferring India M&S

India
Not specified
Safety information reporting
Periodic safety update reports submission
Dossier preparation for submissions
Ferring India M&S is seeking an Executive in Regulatory Affairs & Pharmacovigilance with at least one year of experience in the pharmaceutical or biotech industry. The role involves reporting safety information, preparing regulatory submissions, and ensuring compliance with Indian regulations. ###

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, and review safety mailbox for the reports.
  • Responsibilities involve the submission of Periodic Safety Update Reports to the regulatory authority as per regulations and gathering requirements for dossier preparation for Indian regulatory authority for new products, clinical trials, variations, and renewals.
  • The role also includes preparation of dossiers for regulatory submissions and follow-ups for South Asia countries, preparation and updation of labeling materials, promotional material review, and timely information for updation of Regulatory Databases.

Matching Summary

Match Score: 75

Ferring India M&S is seeking an Executive in Regulatory Affairs & Pharmacovigilance with at least one year of experience in the pharmaceutical or biotech industry. The role involves reporting safety information, preparing regulatory submissions, and ensuring compliance with Indian regulations. ###

Skills & Requirements

Must-have

  • Safety information reporting
  • Periodic Safety Update Reports submission
  • Dossier preparation for submissions
  • Promotional material review
  • Local SOP updation

Nice-to-have

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

Key Requirements

  • 1+ years in India Regulatory Affairs
  • 1+ years in Pharmacovigilance functions
  • Bachelors in Pharmacy or Lifesciences or Microbiology, Chemistry, or similar

Work Rights

Not specified

Tailored Resume

Cover Letter