Safety Data Analyst

5 days ago

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

We are seeking a skilled professional to join our team as a Pharmacovigilance Associate.

The successful candidate will be responsible for retrieving and preparing data for authoring selected Periodic Safety Update Reports (PSURs), reviewing and performing quality control on the data retrieval procedures and selected PSUR sections, finalizing PSURs including the creation of PSUR PDFs, drafting responses to requests from regulatory agencies as needed, ensuring all PSUR-related activities are conducted in accordance with established procedures, and fostering collaborative relationships with other functions within the organization.

Key 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.
Requirements
  • Educational Background: A University degree in Pharmacy (B.Pharm, M.Pharm, Pharm.D) is required.
  • Language Skills: Proficiency in English, both written and spoken, is essential.
  • Technical Skills: Experience with databases such as ARISg, Argus, Cognos, Veeva, TrackWise, QlikSense, and proficiency in MS Office (Word, Excel, PowerPoint) is required.
  • Experience: Minimum 1-2 years of experience in Pharmacovigilance, with experience in PSUR/RMP/PADER writing or ICSR/case processing writing is desired.
  • Skills: A strong sense of compliance and ability to meet deadlines is necessary.
Reports To:

This position reports directly to the PV Manager, Aggregate Reports Expert.

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