Senior Executive, Patient Safety

Advanz Pharma Corp; Mumbai; Hybrid; INR 900,000 - 1,300,000; Full time

Job summary

ADVANZ PHARMA is seeking a Senior Executive, Patient Safety to join the Medical Office team in Mumbai. Hybrid work arrangement in Andheri, Mumbai.

The role focuses on safety data exchange agreements, PSMFs, and regulatory compliance across global operations, collaborating with internal stakeholders and external partners to maintain an excellent pharmacovigilance framework. You will contribute to inspections readiness, CAPA management, and literature surveillance while upholding the company

Qualifications

• University degree in a Life Science.
• Extensive experience in Pharmacovigilance compliance.
• Experience supporting Pharmacovigilance audits and inspections.
• Strong stakeholder management and collaboration.

Responsibilities

• Write, track, and maintain SDEAs and PSMFs.
• Serve as PV contact for stakeholders and partners.
• Support global/regional PSMFs and annexes.
• Coordinate PV audits and CAPA management.
• Maintain literature surveillance and regulatory intelligence.

Skills

Pharmacovigilance

SDEA management

PSMF management

PV audits

Regulatory knowledge

Cross-functional

Communication skills

Education

Life science degree

Job description

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Job Title:Senior Executive, Patient Safety

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 aSenior Executive, Patient Safety to join ourMedical Office team.

The Senior Executive, Patient Safety plays an active role within the Patient Safety Team of ADVANZ PHARMA. This role shall be accountable for writing and supporting in activities related to safety data exchange agreements and PSMF. Must support in all activities related to Safety Data Exchange Agreements (SDEAs) and Pharmacovigilance System Master Files (PSMFs) in ADVANZ PHARMA's global operations. The role shall be responsible for ensuring that the activities are conducted in compliance with applicable pharmacovigilance regulations and internal procedures, maintaining inspection readiness. 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

• Writing, tracking, and maintaining SDEAs, along with reconciliation and PSMFs.
• Be the point of contact for partners and internal stakeholders to get the agreements reviewed and finalized.
• Maintain and update the SDEA tracking system, ensuring agreement obligations and responsibilities are appropriately captured in the responsibility matrix.
• Serve as the primary PV contact for internal stakeholders and external business partners regarding SDEA-related matters.
• Support in writing and maintenance of global and regional PSMFs, ensuring accuracy, completeness, and compliance with applicable regulatory requirements.
• Support the maintenance of PSMF annexes and supporting documentation and coordinate contributions from relevant stakeholders.
• Support the organisation during PV audits and inspections, including preparation activities and management of resulting CAPAs.
• Ensure effective management of local literature surveillance and regulatory intelligence activities.
• 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 programs.
• Experience supporting Pharmacovigilance audits and inspections.
• Experience managing cross‑functional and external stakeholder relationships.
• Strong understanding of Pharmacovigilance regulations, including EU GVP, UK, and regional requirements.
• Self‑aware, 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.