Pharmacovigilance Assessor

TCS is hiring for

PV Agreement Role !!!

Location - Mumbai

Experience - A minimum 2-3 years of experience in Pharmacovigilance. Good working knowledge of the global pharmaceutical/pharmacovigilance regulations (ICH/ Good Pharmacovigilance modules). Expertise on pharmacovigilance for contractual arrangements including Global and Local Pharmacovigilance Agreements.

Job Description -

Draft PVAs (new or revisions) to ensure consistency with company requirements Review PVAs to ensure the quality of the new/revised PVAs and verify that they are consistent with company requirements Address company comments and Collaborating Company’s comments as applicable for PVAs Manage dedicated PVA mailbox Announce new/revised PVAs to all relevant client stakeholders Maintain PVA tracker for all active global PVAs, including reconciliations and updates. Perform compliance monitoring of the effective PVAs and prepare applicable dashboards Assist Project Manager/Designee in managing and updating project related documents/trackers, as applicable. Upload and maintain PVA and associated documentation in company PVA repository Attend team meetings to provide status updates and updates of any issues identified during day-to-day operations with PVAs as needed.

Interested candidates can apply for the role!!!

Best Regards, Megha Dixit - TCS HR