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 Companys 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

Pharmacovigilance Assessor