Vikas Kothawade

Experience

1. Assistant Manager

   Tata Consultancy Services

   Nov 2022 — Present · Mumbai, IN

   Handling of Pharmacovigilance Agreements (PVA’s) and Safety Data Exchange Agreements (SDEA’s): Drafting and Review of Assigned Global Pharmacovigilance Agreements to ensure that they are consistent with company requirements and aligned to the specific contract. Negotiate Global Pharmacovigilance Agreements with Business/Alliance partners Address KSH comments and business partner comments as applicable PVA. Announced new/revised Global Pharmacovigilance Agreements to all KSH. Schedule and facilitate meetings with KSHs and Alliance Partners as needed for PVA and prepare MOM. Attend Periodic Global Pharmacovigilance Agreements status update meeting internal/external as required. Working on PVA terminations, Initiate and Handled Alliance Partners and KSH meetings for discussions related to PVA terminations. Drafting, Review, KSH review and Announcement of Termination of PVA Agreements Working on Device Vigilance Agreement: Preparation of Device Vigilance Agreement template, Kick of Meeting with different Stakeholders, Preparation of Device Draft agreement, KSH review, involved in negotiations with Alliance Partner. Initiate Major and Minor amendments of PVAs as per updates received from KSH and Alliance Partners. Compliance Monitoring of PVA’s/SDEA’s: Perform Regulatory Compliance monitoring of the effective Global Pharmacovigilance Agreements (ICSR, Reconciliation, Aggregate Reports, Risk Management Plan (RMP), Signal Detection, Health Authority Requests, Audit, and Inspection, PSMF, Active/Planned Studies, Exchange of Labels. Every month prepare compliance monitoring dashboards. Review of PVA compliance monitoring dashboards, source emails, checking of compliance against PVA’s. Handling of Other PVA related Responsibilities: Agreements and Compliance Monitoring of Pharmacovigilance Agreements. Maintain Master Index for all Global Pharmacovigilance Agreements

Education

• Pravara Rural Education Societys Pravara Rural College of Pharmacy, Pravaranagar, Dist.Ahmednagar 413736

  Bachelor of Pharmacy - BPharm

• Dr.D.Y. Patil Institute Of Pharmacy

  M.pharmacy, Pharmaceutics