Global PV Partnership & Operations Director

Key Responsibilities: Functional leadership and team management Lead the PV Partnership & Operations function, assigning and coordinating activities across the team, setting strategic direction, priorities, operating model, governance structures and performance expectations. Provide overall accountability for the function’s activities, deliverables, quality, compliance, risk management, performance monitoring and inspection readiness. Highlighting areas of concern to GPV Management Lead, develop and oversee the PV Partnership & Operations team, including resource management, recruitment, performance management, capability building, coaching, escalation support and succession planning. Partnership governance and pharmacovigilance agreements Provide PV functional leadership for new and existing Sobi partner collaborations, including alliance leadership, operational activities, PV process alignment, governance meetings and escalation processes. Accountable for that partner and distributor obligations under PVAs and SDEAs are clearly defined, implemented and fulfilled. Accountable for case exchange elements in Pharmacovigilance Agreements and Safety Data Exchange Agreements (inc oversight and reconciliation). Identification of delivery gaps and development and delivery of appropriate corrective actions. Maintain oversight of case exchange quality, timeliness, completeness and reconciliation activities, ensuring discrepancies are investigated and resolved appropriately. Work with PV VM team, and through the VM Team if applicable with the Sobi PV eESPs, to understand concerns on performance and quality, and to develop and implement appropriate corrective actions. Clinical studies, marketed products and safety data management Work with the ODT Tech lead and OSIRIS Config team to ensure the appropriate configuration for products, clinical trials and marketing authorisations. Lead the development of, and overall accountability, for “study level” Safety Management Plans across Sobi functions and external service providers, ensuring clear roles and responsibilities and delivery and quality expectations for case management and safety reporting within clinical studies. Accountable for study training of case processing vendor Oversee collaboration with Clinical Operations, Global Regulatory Affairs, Contract Research Organisations, Clinical Data Management and other stakeholders to ensure appropriate transfer, reconciliation and reporting of safety data. Accountable for preparation, approval and maintenance of “product level” case-processing Product Safety Information guides and appropriate assessment of Market Research and Patient Support Program materials for PV impact. Quality, compliance, audits and inspections Work closely with GPV Excellence, Sobi QA, PV VM, other Sobi function and external vendors to we ensure quality and compliance standards and defined and maintained for PV activities with “partners”. Ensure quality and compliance of PV Partnership & Operations activities, including proactive identification and management of operational, quality and compliance risks. Work with Safety Science Leads to ensure individual case safety data are of appropriate quality to support aggregate reporting and signal management activities and ensure feedback, with appropriate corrective measures, to case processing vendor Act as the senior subject matter expert for audits and inspections relating to PV Partnership & Operations activities Oversee non-conformance investigations, corrective and preventive actions, issue escalation, inspection readiness, and preparation, coordination and follow-up of relevant audits and regulatory inspections. PV systems, databases and cross-functional collaboration Responsible for ensuring that new and/or changed PV partnerships, study or product activities that impact the Sobi PV system and Sobi PV Vendor operations are appropriately flagged and addressed by the responsible teams (inc Sobi PV VM, Osiris Configuration team). Together with responsible functions, ensuring systems are set up and functioning appropriately to meet Sobi GPV PV commitments. Leadership of the PV Partnership team contribution to company acquisitions, product integrations and other business development activities with impact on the Sobi PV system. Including contribution to the future PV operating model, clear alignment of roles and responsibilities between Sobi PV and a partner, design and delivery of a PV data migration and integration of products and activities into the Sobi PV system.  PV system configuration and operational readiness across products, Oversight of the respective PV Partnership Manager in the design, set up, operations and close out of the PV system to support Sobi sponsored clinical studies and ISSs Accountable for the Drug Safety inbox and to ensure oversight and continued coverage by the team. Serve as the senior functional interface between PV Operations, Safety Science and relevant Sobi business functions on product-specific and process-related matters (e.g. case processing questions). Education/Learning Experience/Work Experience Required: University level qualification in biosciences, healthcare or pharmacy. At least 10 years of relevant pharmacovigilance experience within the pharmaceutical industry, including strong experience in case processing, clinical study safety data management, partner/vendor oversight and applicable GVP, GCP and global regulatory requirements. Experience leading and developing teams, including effective people management, supervision, capability building and prioritisation of work in a complex operational environment. Strong organisational, planning, prioritisation and problem-solving skills. Desired: Working knowledge of IQVIA Vigilance Platform. Previous international / global people management experience. Skills/Knowledge/Languages Thorough knowledge of GVP and GCP. Fluent English, written and spoken. Personal Attributes Ability to work effect