Lead Pharmacovigilance Specialist

4 days ago

Bengaluru, Karnataka, India beBeePharmacovigilance Full time ₹ 1,04,000 - ₹ 1,30,878

Our team is seeking a skilled Pharmacovigilance Specialist to join our organization.

The ideal candidate will have experience in Pharmacovigilance, with a strong understanding of PSUR/RMP/PADER writing or ICSR/case processing writing.

Responsibilities:

  • Data Retrieval: Retrieve and prepare data for authoring selected Periodic Safety Update Reports (PSURs).
  • Review and Quality Control: Review and perform quality control on the data retrieval procedures and selected PSUR sections.
  • PSUR Finalization: Finalize PSURs, including the creation of PSUR PDFs.
  • Regulatory Responses: Draft responses to requests from regulatory agencies as needed.
  • Compliance: Ensure all PSUR-related activities are conducted in accordance with established procedures.
  • Collaboration: Foster collaborative relationships with other functions within the organization.
  • Additional Tasks: Perform other tasks as assigned by your direct manager.

Requirements:

  • Educational Background: University degree in Pharmacy (B.Pharm, M.Pharm, Pharm.D).
  • Language Skills: Proficiency in English, both written and spoken.
  • Technical Skills: Experience with databases such as ARISg, Argus, Cognos, Veeva, TrackWise, QlikSense, and proficiency in MS Office (Word, Excel, PowerPoint).
  • Experience: Minimum 1-2 years in Pharmacovigilance.

Reports To:

  • Position: PV Manager, Aggregate Reports Expert

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