Aakaash Pandey

Deputy Manager- International Pharmcovigilance Manager/QPPV/SDEA/PSMF/ Aggregate Reports/RMP/REMS/Compliance/ Audits/Literature/Signal detection/ICSR Management/Vendor Management

Role
Deputy Manager- Pharmacovigilance at Synokem Pharmaceuticals Ltd
Location
New Delhi, DL, IN
LinkedIn followers
500 followers
Healthcare & Human ServicesView LinkedIn profile

About Aakaash Pandey

As Deputy Manager Pharmacovigilance at Synokem Pharmaceuticals and its subsidiaries—Nitin…

Experience

  1. Deputy Manager- Pharmacovigilance

    Synokem Pharmaceuticals Ltd

    Aug 2024 — Present · New Delhi, IN

    To act as a Pharmacovigilance Officer-In-Charge (PVOIC).• Responsible for preparation, review and updation of department SOPs• Responsible for ICSRs management and submission to regulatory authority• Preparations of Periodic Update Safety Reports and ensure timely submission to Health Authorities (USFDA, EMEA, DCG(I))• Responsible for preparation and compliance of Safety Data Exchange Agreement (SDEA) with marketing partners• To prepare Risk Management Plan (RMPs) according to the SOP and regulatory requirements.• To review and assessment of literature reports regarding adverse events related to the company products, identify Individual Case Safety Reports and other safety related findings.• Responsible to provide pharmacovigilance related trainings• Facing all PV audits and regulatory inspections• Responsible for effective compliance of all PV system.• Any other additional responsibility as assigned by HOD.

Education

  • Galgotias University

    Bachelor of Pharmacy - BPharm

    2012 — 2016

  • Cliniminds Institution

    Advanced post graduate diploma in Clinical research and Pharmacovigilance

    2017 — 2018

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Aakaash Pandey — Deputy Manager- Pharmacovigilance at Synokem Pharmaceuticals Ltd in New Delhi, DL, IN | Unifers