Manager, Patient Safety

Advanz Pharma Corp; Mumbai; Hybrid; INR 2,500,000 - 4,000,000; Full time

Benefits offered by this job

Global recognition programme

Long Service Award

Employee Assistance programme

Birthday leave

Volunteering leave

Agile working

Work from Anywhere subject to localleg

Job summary

ADVANZ PHARMA in Mumbai (Hybrid) is seeking a Manager Patient Safety to join the Medical Office team. You will oversee Pharmacovigilance System Master Files (PSMFs), Safety Data Exchange Agreements (SDEAs), and the annual PV training program while supporting new joiners globally.

You will ensure compliance with EU GVP, UK and regional PV requirements, maintain inspection readiness, and partner with internal and external stakeholders to drive continuous improvement.

Qualifications

• University degree in a Life Science.
• Extensive experience in Pharmacovigilance compliance incl. SDEAs, PSMFs and PV training.
• Experience supporting PV audits and inspections.
• Experience managing cross-functional and external stakeholder relationships.
• Experience leading compliance and process improvement in PV.
• Strong understanding of PV regs (EU GVP, UK, regional).

Responsibilities

• Write and manage SDEAs and PSMFs.
• Lead negotiation, review, execution, maintenance of SDEAs with partners.
• Update SDEAs and trackers to stay current with guidelines.
• Serve as primary PV contact for internal/external stakeholders on SDEA matters.
• Oversee PSMF preparation, maintenance, review, and regulatory compliance.
• Establish inspection-ready processes and documentation for audits.
• Lead PV training programs, materials, and compliance metrics.
• Deliver PV and GVP training to internal personnel and external partners.
• Monitor training compliance and implement CAPA as needed.
• Assist in SOPs/WIs/templates and PV documentation.
• Stay updated on evolving PV regulations and best practices.
• Collaborate across functions with openness and accountability.

Skills

PV compliance

SDEA management

PSMF management

PV training

Stakeholder management

Regulatory knowledge

Communication

Education

Life Science degree

Job description

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Location:Andheri, Mumbai (Hybrid working)

About the Role

AsADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we are seeking aManager Patient Safety to join ourMedical Office team.

This role will be accountable for managing Pharmacovigilance System Master Files (PSMFs), Safety Data Exchange Agreements (SDEAs), and a yearly Pharmacovigilance training program and ongoing PV training for new joiners in ADVANZ PHARMA's global PV operations.

The role must ensure that these activities are conducted in compliance with applicable pharmacovigilance regulations and internal procedures, maintaining inspection readiness, and supporting continuous improvement of the pharmacovigilance system. The position requires effective collaboration with internal stakeholders and external business partners to ensure ongoing compliance, operational excellence, and maintenance of a robust pharmacovigilance framework.

What You'll Be Responsible For

• Act as the subject matter expert for writing and managing SDEAs and PSMFs.
• Lead the negotiation, review, execution, maintenance, and periodic reconciliation of SDEAs with all ADVANZ PHARMA partners (co-licensing, co-development, distribution and local PV persons).
• Ensure all SDEAs and their respective obligations are updated in line with respective guidelines and all trackers are most up to date ed.
• Serve as the primary PV contact for internal stakeholders and external business partners regarding SDEA-related matters.
• Oversee the preparation, maintenance, review, quality control, approval, and periodic update of global and regional PSMFs, ensuring accuracy, completeness, and compliance with applicable regulatory requirements.
• Establish and maintain inspection-ready processes and documentation, supporting audits and inspections from PSMF and SDEA's perspective.
• Lead the development, maintenance, implementation, and continuous improvement of PV training programs, materials, and compliance metrics.
• Ensure delivery and documentation of PV and GVP training to internal personnel and external partners, as applicable.
• Monitor training compliance and effectiveness, identifying and implementing corrective and preventive actions where required.
• Participate in the preparation, review, and maintenance of Standard Operating Procedures (SOPs), Work Instructions (WIs), templates, and associated PV documentation.
• Maintain awareness of evolving global Pharmacovigilance regulations and industry best practices and ensure implementation of relevant requirements within the area of responsibility.
• Thrive in an entrepreneurial environment and take accountability for results.
• Embrace challenge and change, applying a growth mindset approach.
• Have a bias for action and fast decision-making.
• Consistently demonstrate and embody company core values: Entrepreneurship, Speed, and Integrity.
• Drive the spirit of “One Team” by working collaboratively across all business functions with open, honest, and respectful cooperation.
• Contribute to making ADVANZ PHARMA a desired place to work.

What We're Looking For

We're looking for ambitious, resilient, and commercially minded professionals who are passionate about improving patient outcomes and driving business growth.

For this role, you will also have the following:

Qualifications:

• University degree in a Life Science.

Knowledge, Skills & Experience:

• Extensive experience in Pharmacovigilance compliance, including management of SDEAs, PSMFs, and PV training programmes.
• Experience supporting Pharmacovigilance audits and inspections.
• Experience managing cross-functional and external stakeholder relationships.
• Experience leading compliance and process improvement initiatives within Pharmacovigilance.
• Strong understanding of Pharmacovigilance regulations, including EU GVP, UK, and regional requirements.
• Self-aware, strategic mindset, results-driven, stakeholder-centric focus, team player, and willing to take accountability.
• Excellent communication skills, both oral and written, to connect with senior management internally & in third-party suppliersor service providers.
• A positive and ‘can-do’ approach , biased towards finding solutions and embracing change
• Inspired by our values of entrepreneurship, speed, and integrity.
• Learning agility and ‘scalability’, with a desire to continuously improve and develop as ADVANZ PHARMA grows.
• Work collaboratively across all business functions with open, honest, and respectful cooperation.
• Ability to have fun and thrive in a growing, unique, and inclusive work environment.

At ADVANZ PHARMA, our purpose is clear: improving patients' lives by increasing access to medicines that matter. We are a fast-growing international pharmaceutical company where employees have the opportunity to make a tangible impact, take ownership, and contribute to meaningful work every day.

A Place Where You Can Grow

We foster a culture built on trust, collaboration, inclusion, and continuous development. Whether you're expanding your commercial expertise, taking on new challenges, or building your career within a growing organisation, you'll be supported to succeed.

Entrepreneurial by Nature

Our teams are empowered to make decisions, challenge convention, and create solutions that drive results. We value people who bring energy, accountability, and a desire to make things happen.

A Meaningful Mission

Every role at ADVANZ PHARMA contributes to improving access to important therapies for patients across the globe. The work you do will have a direct impact on healthcare professionals, healthcare systems, and ultimately the patients they serve.

Flexibility and Support for Your Wellbeing

Our agile and flexible working arrangements, paired with a comprehensive compensation and benefits package, are designed to support your health, career aspirations, and work-life balance.

We are delighted to offer a comprehensive package designed to support the health, well-being, and professional growth of our employees.

• Global recognition programme
• Long Service Award
• Employee Assistance programme
• Birthday leave
• Volunteering leave
• Agile working [ for office-based employees only ]
• Work from Anywhere subject to local legislation [ for non-field-based employees only ]

Our People Recommend Us

We're proud that 82% of employees in our 2026 engagement survey said they would recommend ADVANZ PHARMA as a great place to work.