Manager Patient Safety (Mumbai)

Manager Patient Safety (Mumbai)

08 Oct
|
Advanz Pharma
|
Mumbai

08 Oct

Advanz Pharma

Mumbai

? We're Hiring | Manager Patient Safety ? Mumbai (Andheri) | Hybrid

ADVANZ PHARMA is looking for an experienced Manager, Patient Safety to join our Medical Office team and help strengthen our global pharmacovigilance operations.

In this role, you'll lead the management of:
• Lead the development, review, execution, and maintenance of Safety Data Exchange Agreements (SDEAs) across global business partnerships, ensuring regulatory compliance and timely updates.
• Manage and maintain Pharmacovigilance System Master Files (PSMFs), ensuring accuracy, completeness, and inspection readiness across all applicable regions.
• Serve as the subject matter expert for PV compliance documentation, providing guidance to internal stakeholders and external partners on SDEA and PSMF requirements.
• Ensure compliance with global Pharmacovigilance regulations, including EU GVP, UK, and other regional requirements through effective governance and oversight.
• Develop, implement, and oversee global PV training programs, ensuring timely delivery and documentation of mandatory Pharmacovigilance training.




• Monitor and drive PV training compliance metrics, identifying gaps and implementing corrective and preventive actions (CAPAs) where required.
• Support and coordinate Pharmacovigilance audits and regulatory inspections, maintaining inspection-ready documentation and facilitating successful outcomes.
• Collaborate with cross-functional teams and external business partners to strengthen PV operational processes and ensure fulfillment of contractual safety obligations.
• Drive continuous improvement initiatives within the Pharmacovigilance system, enhancing process efficiency, compliance, and operational excellence.
• Contribute to the development and maintenance of PV quality documents, including SOPs, Work Instructions, templates, and compliance trackers, while promoting a culture of integrity, accountability, and collaboration.

? We're looking for professionals with:
• A Life Sciences

📌 Manager Patient Safety (Mumbai)
🏢 Advanz Pharma
📍 Mumbai

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