Ankush Kumar
Pharmacovigilance officer at Medriech Pharmacovigilance || Aggregate Reporting || Medical Writing|| ICSR || Signal Data Management II Risk Management Plan
- Role
- Pharmacovigilance Officer at Medreich Limited
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Ankush Kumar
Receive, track, and triage Individual Case Safety Reports (ICSRs).* Collaborate with cross-functional teams to resolve issues during safety data review and report preparation.* Ensure timely submission of reports to meet regulatory compliance.* Set up search strategies and monitor literature databases for relevant safety information.* Perform initial review of literature articles, segregating them into ICSRs, AOIs, and other relevant categories.* Conduct duplicate searches and ensure case processing aligns with SOPs.* Review case quality against source documents.* Collect safety data and prepare Risk Management Plans (RMP), PBRERs/PSURs and addendums to clinical overview summaries.* Respond to medical, pharmaceutical, and technical inquiries, including adverse events (AEs).* Maintain records and ensure timely responses to inquiries.* Report adverse events to the case processing team.
Experience
Pharmacovigilance Officer
Dec 2024 — Present · Bengaluru, IN
Education
Kurukshetra University
Bachelor of Science - BS, med
2015 — 2018
Chitkara University
Master's degree, pharmacovigilance & clinical research
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