Executive / Senior Executive - Pharmacovigilance Agreements Specialist

Why This Role Matters

Pharmacovigilance Agreements (PVAs) are critical legal and operational documents that define safety responsibilities between marketing authorization holders and partners. A well-drafted and compliant PVA ensures clear accountability, regulatory compliance, and seamless safety data exchange across global stakeholders.
At Tata Consultancy Services (TCS), this role supports global clients within Business Process Services by drafting, reviewing, and managing PVAs in alignment with international pharmacovigilance regulations and company standards.

Job Description

TCS is hiring experienced Pharmacovigilance professionals for the role of Executive / Senior Executive – Pharmacovigilance Agreements Specialist in Mumbai.
The position focuses on drafting, reviewing, maintaining, and monitoring Global and Local Pharmacovigilance Agreements while ensuring compliance with ICH guidelines and Good Pharmacovigilance Practices (GVP).

Key Features of the Role

• Draft and review Global and Local Pharmacovigilance Agreements (PVAs)
• Ensure compliance with ICH and global GVP regulations
• Manage PVA trackers, repositories, and reconciliation activities
• Monitor compliance of effective PVAs and prepare dashboards
• Coordinate with cross-functional and client stakeholders
• Manage PVA mailbox and communication workflows
• Support project documentation and operational updates

Responsibilities

• Draft new PVAs and revise existing agreements as per company standards
• Review PVAs for quality, completeness, and regulatory alignment
• Address internal and collaborating company comments on agreements
• Manage dedicated PVA mailbox and ensure timely communication
• Announce new or revised PVAs to relevant stakeholders
• Maintain and update global PVA trackers including reconciliation activities
• Perform compliance monitoring of active PVAs and prepare dashboards
• Upload and maintain PVA documentation in company repository systems
• Assist Project Manager or designee in updating project trackers and documentation
• Attend team meetings and provide updates on PVA status and operational issues

Required Qualifications

• 3–7 years of experience in Pharmacovigilance
• Strong knowledge of global pharmacovigilance regulations (ICH, GVP Modules)
• Hands-on expertise in drafting and managing Global and Local PV Agreements
• Experience handling contractual pharmacovigilance arrangements

Educational Requirements

• Bachelor of Pharmacy (B.Pharm)
• Master of Pharmacy (M.Pharm)
• Bachelor of Science (B.Sc)
• Master of Science (M.Sc)

Experience and Skills

• Strong understanding of contractual PV obligations
• Experience managing PVA trackers and compliance dashboards
• Knowledge of global regulatory frameworks and safety exchange processes
• Excellent documentation, communication, and stakeholder coordination skills
• Proficiency in MS Office tools
• Ability to manage multiple agreements and timelines simultaneously

Salary Insights

• Competitive compensation aligned with experience
• Opportunity to work with global pharmaceutical clients
• Exposure to international contractual pharmacovigilance frameworks

FAQs

Q: Is prior PVA drafting experience mandatory?
Yes, hands-on experience with Global and Local PV Agreements is required.

Q: Does the role involve client interaction?
Yes, coordination with collaborating companies and internal stakeholders is part of the role.

Q: Is regulatory knowledge important?
Strong understanding of ICH and GVP modules is essential.

Application Tips

• Clearly mention PVA drafting and review experience
• Highlight exposure to global pharmacovigilance regulations
• Include examples of compliance monitoring or dashboard preparation
• Emphasize stakeholder coordination and documentation management skills