TCS is Hiring for Pharmacovigilance Agreements Specialist
Experience:
- A minimum 3-7 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.
Job Function
BUSINESS PROCESS SERVICES
Desired Skills
Pharmacovigilance
Desired Candidate Profile
Qualifications : BACHELOR OF PHARMACY, BACHELOR OF SCIENCE (B.Sc)
