Pharmacovigilance Licensing Manager

Pharmacovigilance Licensing Manager

Sobi

Stockholm, Sweden

We are seeking a dynamic and experienced Senior Pharmacovigilance Agreements Manager to join our team. As a key member of our Global Pharmacovigilance Agreements (PVA) team, you will play a crucial role in managing strategic collaborations and alliances to ensure the highest standards of patient safety and regulatory compliance.

Job Description

Key Responsibilities:

• Own the end-to-end lifecycle of Pharmacovigilance Agreements (PVAs), including development, execution, maintenance, and termination where applicable, along with all associated deliverables. Contribute to strategy setting in collaboration with line management as required, ensuring compliant and efficient solutions for all parties.
• 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.

Qualifications

• 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.