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 for Regulatory Affairs & Pharmacovigilance, focusing on the reporting and compliance of safety information and regulatory submissions within the Indian and South Asian markets. The ideal candidate should have a Bachelor’s degree in Pharmacy or related fields and at least one year of experience in regulatory affairs and pharmacovigilance in the pharmaceutical or biotech industry

Job Summary

  • The key activities include reporting of safety information from India & India cluster to Global Safety, follow up for additional information with reporters, and review of the safety mailbox for 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 submissions.
  • The role also includes preparation of dossiers for regulatory submissions and follow-ups for South Asia countries, preparation and updation of labeling materials, and promotional material review.

Matching Summary

Match Score: 75

Ferring India M&S is seeking an Executive for Regulatory Affairs & Pharmacovigilance, focusing on the reporting and compliance of safety information and regulatory submissions within the Indian and South Asian markets. The ideal candidate should have a Bachelor’s degree in Pharmacy or related fields and at least one year of experience in regulatory affairs and pharmacovigilance in the pharmaceutical or biotech industry.

Skills & Requirements

Must-have

  • Safety information reporting
  • Periodic Safety Update Reports submission
  • 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
  • Bachelors in Pharmacy or Lifesciences

Work Rights

Not specified

Tailored Resume

Cover Letter