Senior Pharmacovigilance Licensing Manager

Company Description

At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

Here At Sobi, Our Mission And Culture Get Us Excited To Come To Work Every Day, But Here Are a Few More Reasons To Join Our Team

• Competitive compensation for your work
• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Opportunities for professional growth
• Diversity and Inclusion
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

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

• 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.
• Develop and implement a comprehensive pharmacovigilance collaboration strategy focused on effective communication, data exchange, compliance, and risk management.
• Represent the PVA function in internal and external meetings, providing updates, insights, and guidance on pharmacovigilance collaborations and activities.
• 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.
• Act as deputy for the Global PV Licensing Director as required.

• Bachelor's degree preferably in Life Sciences or relevant scientific discipline
• Minimum of 5 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 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 time frames.
• Leadership skills for leading meetings, negotiation teams, and training.
• Proficiency in written and spoken English; knowledge of other languages is advantageous

If you are a motivated professional with a passion for patient safety, collaboration, and regulatory compliance, we invite you to join our Global PV team, develop and maintain our PV system to deliver our portfolio of product for rare disease to patients across the globe and make a significant impact in our organisation.

Apply now and help us shape the future of patient safety through strategic alliances and partnerships.

To apply, please submit your resume and a cover letter detailing your relevant experience and accomplishments.

All Sobi employees need to demonstrate behaviors in line with Sobi's core values:
Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi…