The Associate Director, International GVP Compliance plays a critical role in ensuring the effective implementation and execution of Positive Pharmacovigilance Practice (GVP) compliance across assigned international regions. This position partners closely with Local Operating Companies (LOCs), regional Patient Safety and Pharmacovigilance (PSPV) stakeholders, and Global GVP Compliance teams to translate global compliance strategies into consistent regional practices.

Key Responsibilities:
GVP Compliance Leadership

GVP Quality Systems
- Execute and support core GVP Quality System processes regionally, including deviations, investigations, CAPA management, change control, and escalation.
- Lead high-quality investigations and root-cause analysis, ensuring patient-safety focus and effective prevention of recurrence.
- Track, monitor, and support CAPA development, implementation, and effectiveness, escalating risks, delays, or systemic issues to regional leadership as appropriate.

Inspection Readiness, Audits & Inspections
- Manage regional inspection readiness activities,



helping embed readiness into routine PV operations rather than point-in-time preparation.
- Lead in regional and LOC-level audits and regulatory inspections, supporting preparation, inspection conduct, response development, and follow-up activities.
- Partner with the Director, Regional GVP Compliance, EU QPPV and PSPV to support aligned inspection messaging, issue tracking, and corrective actions.

Compliance Risk Management & Governance
- Drive proactive identification and assessment of regional compliance risks by analyzing audit outcomes, inspection findings, KQIs, and compliance data.
- Contribute regional insights to risk discussions and governance forums, supporting preparation of materials for Management Review and Clinical & Safety Quality Councils.
- Ensure consistent, timely escalation of critical compliance issues, providing analysis and recommendations to regional leadership.

Continuous I

📌 Associate Director, International Gvp Compliance (Bengaluru)
🏢 Takeda Pharmaceutical
📍 Bengaluru