P SANJEEV KUMAR

To seek an environment that encourages learning and creativity, providing exposure to new ideas, stimulating personal and professional growth in the field of Drug Safety (PV).

• Perform initial triage of the received safety notifications.
• Evaluate the medical coding of adverse events, medical and past drug history, indications, and diagnostics using MedDRA.
• Process Individual Case Safety Reports (ICSRs), including data entry in Argus safety database.
• Perform follow-up ICSRs with the reporter, generate follow up (FU) queries and send FU requests. Identifying clinically relevant missing information and initiate follow-ups for the collection of new and clinically significant data as well as for medical confirmations as required.
• Writing a detailed medically oriented description of the events in the form of safety narrative
• Review literature screening search results, identifying ICSRs and other safety-related findings. Peer review/QC of ICSRs Drafted by DE. Literature reference (i.e. journal and article title and author).
• Proactively communicating with the client on a regular basis by emails or telecom for any clarifications required.
• Forward cases for case review or invalid workflow in the global safety database. Review Adverse Event (AE) report data for completeness and verify certain fields to determine as critical (including but not limited to reportability) as well as conformity to E2B standards.
• Correct the data entry errors, if any, prior to routing the case in the global safety database
• Thorough knowledge on interpreting the various line listing documents Achieve professional excellence in quality review, compliance of ICSR.
• Proficient MedDRA and WHO drug dictionary coder (3.5 years of experience in AE, MedDRA coding).

• Argus Safety Database
• PVAI
• Ovid/PubMed
• Windows MS officetools
• RighFind/ CQ Fluency
  

Ø Done Certification Course in Pharmacovigilance, Clinical Research and Clinical Data Management @ Clinnovo Research Labs, Hyderabad. Done internship in Regulatory Affairs at Vins Biologicals.

I do hereby declare that all the information given above is true to the best of my knowledge and belief.