Pharmacovigilance Licensing Manager

Responsibilities

• Collaborate with global functions to provide expert advice and support on commercial agreements, named patient use supplies, and other managed access programs, ensuring optimal and compliant pharmacovigilance obligations are embedded.
• Work closely with internal Patient Safety functions and cross-functional Sobi departments to ensure full alignment with Global Pharmacovigilance (GPV) agreements.
• Oversee and manage pharmacovigilance collaborations and alliances with external business partners, including co-marketing, co-development, distributor partners, and healthcare organizations.
• Lead the negotiation and establishment of pharmacovigilance agreements, clearly defining roles, responsibilities, and conditions to enable seamless collaboration.
• Partner efficiently with the Sobi Global Pharmacovigilance group and other key stakeholders to ensure PVAs are effectively implemented, maintained, and monitored.
• Provide subject matter expertise on current and evolving pharmacovigilance regulations and guidelines, both internally and externally.
• Support pharmacovigilance audits and inspections related to collaborations, including contribution to corrective and preventive action (CAPA) plans.
• Train and educate internal teams on pharmacovigilance standards, procedures, and collaboration requirements.
• Continuously identify opportunities for process improvement, efficiency gains, and risk mitigation across pharmacovigilance collaborations.
• Bachelor's degree preferably in Life Sciences or relevant scientific disciplinee.
• Minimum of 3 years of experience in the pharmaceutical industry, with solid experience in pharmacovigilance, regulatory affairs and or quality assurance, with a focus on safety alliance or collaboration management.
• At least 2-3 years of specific experience in managing patient safety alliances or partnership
• Strong understanding of global and local pharmacovigilance regulations and guidelines.
• Excellent negotiation, communication, and problem-solving skills. Able to drive towards solutions and reach common grounds.
• Proven ability to work effectively in cross-functional and international teams.
• Strong organizational skills with the ability to manage multiple projects, motivated and driven - able to take ownership of a complex agreement process and drive it through to finalisation in agreed timeframes.
• Proficiency in written and spoken English; knowledge of other languages is advantageous.
• To apply, please submit your resume and a cover letter detailing your relevant experience and accomplishments.

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