PV Manager/PV System Management and Agreements Lead

About this role

Responsibilities

• You will be part of a small team of experienced pharmacovigilance (PV) experts, with each member holding similar responsibilities within the QPPV office. For senior experts, there is also the possibility to step into a team leader role. In this position, you will collaborate closely with the QPPV, global PV unit management, subject matter experts, R&D QA (PV auditors), as well as global affiliates and service providers.
• Your responsibilities cover various aspects of maintaining and developing the pharmacovigilance system globally at the company's headquarters PV unit. Weekly duties include:
• Managing pharmacovigilance agreements (with licensing partners and service providers) and due diligence activities
• Organizing pharmacovigilance training
• Overseeing inspections and audit-related work when the pharmacovigilance system is evaluated by authorities or business partners
• Handling GVP deviations, CAPA management, GVP change management, and ensuring GVP compliance
• Supervising affiliate and service provider PV activities
• Maintaining the Pharmacovigilance System Master File
• Coordinating and developing pharmacovigilance business continuity processes
• What you can expect from us
• At Orion, your work creates true impact and well-being for our customers, patients and society at large. Our culture of friendliness, respect, mutual appreciation and diversity creates a safe working environment where you can strive for excellence. We offer a wealth of career paths and development opportunities that support the development of innovative solutions and improving the quality of life.
• Please visit our website to find further information about our values and Orion as an employer https://www.orion.fi/en/careers/orion-as-an-employer/.
• What are we looking for?
• We are seeking a senior expert with a minimum of five years' previous experience in pharmacovigilance activities. The ideal candidate possesses strong cross-functional collaboration a