Manager Patient Safety

ADVANZ PHARMA Corp.; Mumbai; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

ADVANZ PHARMA is seeking an experienced Manager, Patient Safety to join our Medical Office team in Mumbai. You will lead global pharmacovigilance activities including SDEA and PSMF governance, regulatory compliance, and training program development.

You will partner with cross-functional teams and external partners to ensure inspection readiness, quality documents, and continual PV process improvements across regions.

Qualifications

• Life Sciences degree and postgraduate qualification required.
• Strong experience in Pharmacovigilance compliance, SDEAs and PSMFs.
• Knowledge of EU GVP, UK and regional PV regulations.
• Excellent stakeholder management and communication skills.

Responsibilities

• Lead development, review, execution and maintenance of SDEAs across global partnerships.
• Manage Pharmacovigilance System Master Files (PSMFs) for audit readiness.
• Serve as expert for PV compliance documentation and guidance to stakeholders.
• Ensure compliance with global PV regulations including EU GVP and UK.
• Develop and oversee global PV training programs and track compliance metrics.
• Support PV audits and regulatory inspections with prepared documentation.
• Collaborate with cross-functional teams and partners to strengthen PV processes.
• Drive continuous improvement in PV systems and quality documents.

Skills

PV compliance

SDEA management

PSMF management

Regulatory knowledge

Stakeholder management

Communication skills

Education

Life Sciences degree

Postgraduate qualification

Job description

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 degree and postgraduate qualification
• Strong experience in Pharmacovigilance compliance, SDEAs, and PSMFs
• Knowledge of EU GVP, UK, and regional PV regulations
• Excellent stakeholder management and communication skills

At ADVANZ PHARMA, you'll contribute to our mission of improving patients' lives by increasing access to medicines that matter, while working in a collaborative, entrepreneurial, and growth-focused environment.