Global Patient Safety Vendor Oversight Manager

Ipsen is a growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients’ health and quality of life, providing effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences, and Rare Diseases.

Why Ipsen?

• Patient-Focused: The patient is at the heart of everything we do, and improving their outcomes is the deliverable of every strategy.
• Employee Care: We care for our employees, who are the ambassadors making a real difference.
• Bold Leadership: We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions.
• Growth Opportunities: We offer a wealth of fulfilling challenges and growth opportunities in a fast-moving, game-changing organization.

About the Role

The Global Patient Safety (GPS) Vendor Oversight Manager will support the GPS Vendor Oversight Director in developing, implementing, and managing the governance model and oversight strategy for GPS Vendors involved in pharmacovigilance activities. The role will help ensure GPS vendors’ compliance with contractual obligations and performance expectations, while fostering strong partnerships and promoting continuous improvement.

Key Responsibilities

Vendor Oversight and Governance

• Support the development and execution of vendor oversight strategies to ensure the quality and compliance of outsourced pharmacovigilance activities.
• Assist with the implementation and maintenance of strategic vendor oversight
• Assist in defining and monitoring KPIs and metrics to evaluate vendor performance.

Vendor Deviation Management

• Review monthly vendor deviation reports, focusing on root cause analyses and impact assessments.
• Evaluate the adequacy of corrective and preventive actions (CAPAs) and follow up on implementation until closure.

Pharmacovigilance System Master File (PSMF) Oversight

• Support PSMF updates by ensuring that open Global Patient Safety (GPS) Vendor CAPAs are accurately documented.
• Ensure all relevant GPS Vendor Quality Documents (QDs) are maintained and reflected in the PSMF as applicable.

Training Compliance Oversight

• Maintain oversight of vendor training compliance by: Monitoring training completions and vendor employee training curriculums

Vendor Relationship Management

• Act as a point of contact for day-to-day GPS vendor oversight activities.

Collaboration with Internal Stakeholders

• Work closely with relevant GPS functions to monitor and improve vendor performance against contractual and regulatory requirements.
• Support procurement-related activities such as request for proposals, bid defences, and vendor evaluations.

GPS Vendor Audits

• Contribute to audit preparation and activities by reviewing audit agendas, reports, vendor responses, and CAPAs
• Attending onsite audits as needed (travel is required).

Contract budget

• Liaise with GPS Project Associate to ensure appropriate budget is secured for GPS vendor contracts and activities.

Qualifications

• Strong pharmacovigilance operations and vendor experience
• In-depth knowledge of pharmacovigilance regulations (e.g., FDA, EMA, ICH) and guidelines.
• Excellent communication and interpersonal skills, with the ability to build effective relationships with vendors and internal stakeholders.
• Exceptional organizational skills and attention to detail.

Ipsen is committed to fostering a diverse and inclusive workplace where all employees feel valued and empowered. If you feel that this could be the right next step for you, we would be delighted to engage with your application.

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