About the job
Join our innovative team at Sobi as a Senior Pharmacovigilance Licensing Manager. In this pivotal role within our Global Pharmacovigilance Licensing (PVL) team, you will spearhead strategic partnerships and collaborations, ensuring unparalleled patient safety and adherence to regulatory standards.
Key Responsibilities:
- Manage the complete lifecycle of Pharmacovigilance Agreements (PVAs), from development to execution, maintenance, and termination, while collaborating with line management to set strategies that ensure compliance and efficiency.
- Provide expert guidance on commercial agreements, named patient use supplies, and managed access programs, ensuring that pharmacovigilance obligations are optimally integrated.
- Coordinate with internal Patient Safety teams and various Sobi departments to maintain alignment with Global Pharmacovigilance agreements.
- Oversee pharmacovigilance partnerships with external entities such as co-marketing and distributor partners, as well as healthcare organizations.
- Lead negotiations to establish clear pharmacovigilance agreements, defining roles and responsibilities to facilitate effective collaboration.
- Work closely with the Sobi Global Pharmacovigilance group and relevant stakeholders to ensure that PVAs are implemented, maintained, and monitored effectively.
- Offer expertise on current pharmacovigilance regulations and guidelines, ensuring both internal and external compliance.
- Craft and execute a robust pharmacovigilance collaboration strategy focused on communication, data sharing, compliance, and risk management.
- Represent the PVA function in meetings, delivering updates and insights on pharmacovigilance collaborations.
- Assist with pharmacovigilance audits and inspections, contributing to corrective and preventive action (CAPA) plans.
- Educate and train internal teams on pharmacovigilance standards and collaboration requirements.
- Identify opportunities for process enhancements and risk mitigation within pharmacovigilance collaborations.
- Act as deputy for the Global PV Licensing Director when needed.