Manager, Patient Safety

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

Postgraduate qualification Knowledge, Skills & Experience: Extensive experience in Pharmacovigilance compliance, including management of SDEAs, PSMFs, and PV training programmes.