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Multiple Pharmacovigilance and Medical Writing Oppurtunities in Pune, Mumbai

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Fidelity Health Services is hiring for several roles in the pharmacovigilance sector across Mumbai, Pune, and Navi Mumbai. If you have experience in drug safety, medical writing, or safety data management, check out these available positions:

1. Drug Safety Specialist

Location: Mumbai, Pune
Qualification: B. Pharm / M. Pharm / BAMS / BHMS
Experience: 3-4 years in case processing, safety writing, and SDEA management

Key Responsibilities:

  • Manage internal communications with business teams regarding SDEAs
  • Liaise with third parties to establish and maintain SDEAs
  • Conduct adverse event reconciliations and ensure timely data exchange

2. Executive / Sr. Executive – Drug Safety Specialist

Location: Navi Mumbai
Qualification: B. Pharm / M. Pharm
Experience: 5-8 years in Pharmacovigilance, proficiency in MS-Excel, and mailbox management

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Key Responsibilities:

  • Oversee safety reconciliation and compliance activities for clients
  • Conduct data mining and analysis from regulatory databases like FDA’s FAERS
  • Reconcile and update global product safety information

3. Executive Safety Writer / Sr. Executive

Location: Navi Mumbai
Qualification: B. Pharm / M. Pharm / BHMS / BAMS
Experience: 2-4 years in safety writing and aggregate reports

Key Responsibilities:

  • Track submission and approval of aggregate reports
  • Support nonconformance analysis and documentation management

4. Safety Medical Writer

Location: Mumbai
Qualification: M. Pharm / B. Pharm / BAMS / BHMS / BDS
Experience: 2-3 years in drafting and reviewing PADER, PSUR, PBRER, and RMP

Key Responsibilities:

  • Prepare and review various Aggregate Reports (PSUR, PADER, etc.)
  • Collaborate with clients and ICSR teams for strategic AR submissions
  • Generate line listings, identify issues, and provide resolutions

How to Apply:

If you are interested and meet the qualifications, send your CV to hr@fidelityhs.com.