Pharmacovigilance Licensing Manager

This is a fully remote position, open to applicants in Switzerland.

📋 Description

• Take charge of the complete lifecycle of Pharmacovigilance Agreements (PVAs), which includes their development, execution, maintenance, and termination when necessary, along with all related deliverables.

• Collaborate with line management to contribute to the strategic direction, ensuring compliant and efficient solutions for all stakeholders.

• Work alongside global teams to provide expert guidance and support on commercial agreements, named patient use supplies, and other managed access programs, ensuring optimal and compliant pharmacovigilance obligations are integrated.

• Engage closely with internal Patient Safety teams and cross-functional Sobi departments to ensure full alignment with Global Pharmacovigilance (GPV) agreements.

• Oversee and manage pharmacovigilance collaborations and partnerships with external business entities, including co-marketing, co-development, distributor partners, and healthcare organizations.

• Lead negotiations and establish pharmacovigilance agreements, clearly outlining roles, responsibilities, and conditions to enable seamless collaboration.

• Collaborate effectively with the Sobi Global Pharmacovigilance group and other key stakeholders to ensure PVAs are implemented, maintained, and monitored successfully.

• Offer subject matter expertise on current and evolving pharmacovigilance regulations and guidelines, both internally and externally.

• Assist with pharmacovigilance audits and inspections concerning collaborations, including contributions to corrective and preventive action (CAPA) plans.

• Provide training and education to internal teams on pharmacovigilance standards, procedures, and collaboration requirements.

• Continuously identify opportunities for enhancing processes, gaining efficiencies, and mitigating risks across pharmacovigilance collaborations.

⛳️ Requirements

• A Bachelor's degree, preferably in Life Sciences or a relevant scientific field.

• A minimum of 3 years of experience in the pharmaceutical industry, with substantial expertise in pharmacovigilance, regulatory affairs, or quality assurance, particularly focused on safety alliance or collaboration management.

• At least 2-3 years of specific experience in managing patient safety alliances or partnerships.

• A strong understanding of both global and local pharmacovigilance regulations and guidelines.

• Excellent negotiation, communication, and problem-solving abilities.

• Capable of driving towards solutions and finding common ground.

• Demonstrated ability to work effectively in cross-functional and international teams.

• Strong organizational skills with the capacity to manage multiple projects, motivated and driven—able to take ownership of a complex agreement process and see it through to completion within agreed timelines.

• Proficient in written and spoken English; knowledge of additional languages is a plus.

🏝️ Benefits

• Employees have the option to work remotely.