Executive - Regulatory Affairs & Pharmacovigilance job opportunity at Ferring Pharmaceuticals.

Home Jobs In India Tag: Job Executive - Regulatory Affairs & Pharmacovigilance position at Ferring Pharmaceuticals


DateMore Than 30 Days Ago bot
Ferring Pharmaceuticals Executive - Regulatory Affairs & Pharmacovigilance
Experience: General
Pattern: full-time
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degreeBachelor's (B.A.)
loacation Mumbai, India, India
loacation Mumbai, India....India

Job Description: The key activities include: Reporting of safety information from India & India cluster (South Asia countries) to the Global Safety Follow up for additional information with the reporters Review safety mailbox for the reports Monthly Reconciliation and Compliance checks from PV perspective Submission of Periodic Safety Update Reports to the regulatory authority as per regulations 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. , preparation for query responses to the authority, coordination with the global teams Contribute in preparation for regulatory authority meetings and expert committee meetings Preparation of dossiers for regulatory submissions and followups for South Asia countries Preparation and updation of labeling materials for our products Promotional material review in compliance with product registrations Timely information for updation of Regulatory Databases Updation of local SOPs Updation / renewal of  Safety Agreements for Partners, Manufacturers, Distributors Coordination and checks for price updates and entry of information timely into the Pricing Authority database (NPPA) Lifecycle maintenance, and update commercial team in a timely manner of major milestones Qualification: Bachelors in Pharmacy or Lifesciences or Microbiology, Chemistry, or similar Experience: 1 + years in India Regulatory Affairs and Pharmacovigilance functions in Pharma or Biotech Industry Location: Ferring India M&S

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