Sr Executive , Patient Safety

ADVANZ PHARMA Corp.; Mumbai; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Advanz Pharma Corp. in Mumbai seeks a Senior Executive, Patient Safety to strengthen its Medical Office. The role involves leading SDEA tracking, PSMF support, and coordinating with partners to ensure PV regulatory compliance across global operations.

Ideal candidates have PV compliance experience, cross-functional collaboration skills, and a proactive, growth-oriented mindset aligned with Advanz values of speed and integrity.

Qualifications

• Experience in Pharmacovigilance compliance, including SDEAs, PSMFs, and PV training programs.
• Experience supporting Pharmacovigilance audits and inspections.
• Experience managing cross-functional and external stakeholder relationships.
• Strong understanding of PV regulations including EU GVP, UK, and regional requirements.

Responsibilities

• 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, capturing obligations in the responsibility matrix.
• Serve as the primary PV contact for internal stakeholders and external business partners.
• Support in writing and maintenance of global and regional PSMFs, ensuring accuracy and compliance.
• Support the maintenance of PSMF annexes and supporting documentation with stakeholders.
• Assist PV audits and inspections, including preparation activities and CAPA management.
• Ensure local literature surveillance and regulatory intelligence activities are effectively managed.

Skills

Pharmacovigilance

SDEA management

PSMF management

PV audits & inspections

Stakeholder management

Regulatory knowledge

Education

Life Science degree

Postgraduate qualification

Job description

Job Summary

Senior Executive, Patient Safety

Location: Mumbai, India

As Advanz Pharma continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we are seeking a Senior Executive, Patient Safety to join our Medical 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.

Responsibilities

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

Qualifications

• University degree in a Life Science.
• Postgraduate qualification

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 suppliers or 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.