Global PV Partnership & Operations Director

The Global PV Partnership & Operations Director will join Sobi, a biopharmaceutical company focused on creating innovative therapies for rare diseases. In this senior position the director provides strategic oversight for the pharmacovigilance (PV) partnership and operations function, ensuring that Sobi's internal teams, co‑development partners, distributors and external service providers work together efficiently and in compliance with regulatory expectations. On a daily basis the role steers the global PV Partnership & Operations team, assigning tasks, defining priorities and establishing governance structures. It is responsible for the operationalisation of pharmacovigilance agreements, monitoring that both Sobi and its partners meet their commitments, and supervising case‑exchange and reconciliation processes. The director also collaborates closely with the PV Licensing and PV Vendor Management leads to set up agreements, direct vendor delivery and guarantee that all activities are GVP‑ and GCP‑inspection ready. In addition, the role guides the configuration of clinical‑trial systems, the creation of study‑level safety management plans and the preparation of product‑level safety information guides, while ensuring seamless data transfer among clinical operations, regulatory affairs, CROs and data‑management groups. The position calls for proven experience in leading PV partnership activities at a global scale, with a track record of managing cross‑functional teams spread across several countries. Candidates must demonstrate the ability to drive compliance, risk‑management and performance‑monitoring programmes, and to act as an escalation point for complex operational issues. Strong leadership skills are required to recruit, coach and develop the product‑aligned PV Partnership Managers, as well as to plan succession and build capability within the team. While the advert does not list specific certifications or language levels, it highlights the advantage of having familiarity with safety‑data exchange agreements, case‑processing vendor training and the use of tools such as the ODT Tech lead and OSIRIS configuration platforms. The role is situated within a globally distributed team, offering the chance to influence best practices for clinical‑trial operations, vendor management and inspection readiness across Sobi's worldwide network.