Drug Safety Specialist

6 days ago

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

Job Title: Drug Safety Associate

Job Description:
  • Data Retrieval: Gather and prepare data for authorizing specific sections of Periodic Safety Update Reports (PSURs).
  • Quality Control: Review and ensure the accuracy of data retrieval processes and selected PSUR sections.
  • PSUR Finalization: Finalize PSURs, including creating the final PSUR PDFs.
  • Regulatory Responses: Draft responses to requests from regulatory agencies as needed.
  • Compliance: Ensure that all PSUR-related activities are performed according to established procedures.
  • Collaboration: Work closely with other functions to support your role.

 

Qualifications and Skills:
  • Education: 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, with experience in PSUR/RMP/PADER writing or ICSR/case processing writing.
  • Skills: Strong attention to compliance and deadlines.

 

Reports To:
  • Position: PV Manager, Aggregate Reports Expert

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