Executive - Regulatory Affairs & Pharmacovigilance

Ferring India M&S

India
**
Reporting safety information
Review safety mailbox
Monthly reconciliation and compliance checks
** Ferring India M&S is seeking an Executive for Regulatory Affairs & Pharmacovigilance, responsible for reporting safety information, preparing regulatory submissions, and ensuring compliance with local regulations. The ideal candidate should have a Bachelor’s degree in Pharmacy or Lifesciences, along with at least one year of relevant experience in the pharmaceutical or biotech industry. **

Job Summary

  • The key activities include reporting of safety information from India & India cluster to Global Safety, reviewing the safety mailbox, and performing monthly reconciliation and compliance checks from a PV perspective.
  • Responsibilities also involve the submission of Periodic Safety Update Reports, gathering requirements, and preparing dossiers for Indian regulatory authority submissions for new products, clinical trials, variations, and renewals.
  • The role requires preparation of dossiers for regulatory submissions and follow-ups for South Asia countries, updation of labeling materials, promotional material review, and timely information for regulatory databases.

Matching Summary

Match Score: 75

** Ferring India M&S is seeking an Executive for Regulatory Affairs & Pharmacovigilance, responsible for reporting safety information, preparing regulatory submissions, and ensuring compliance with local regulations. The ideal candidate should have a Bachelor’s degree in Pharmacy or Lifesciences, along with at least one year of relevant experience in the pharmaceutical or biotech industry. **

Skills & Requirements

Must-have

  • Reporting safety information
  • Review safety mailbox
  • Monthly Reconciliation and Compliance checks
  • Submission of Periodic Safety Update Reports
  • Preparation of dossiers for submission
  • Promotional material review

Nice-to-have

  • Coordination with global teams
  • Contribution to authority meetings
  • Lifecycle maintenance
  • Timely information updation

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter