Senior Pharmacovigilance Licensing Manager at Sobi

Stockholm, , Sweden -

Full Time

Start Date

Immediate

Expiry Date

13 May, 26

Salary

0.0

Posted On

12 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Pharmacovigilance Agreements, Lifecycle Management, Strategy Setting, Commercial Agreements, Managed Access Programs, Cross-functional Collaboration, Negotiation, Regulatory Compliance, Risk Management, Subject Matter Expertise, Audit Support, Training, Process Improvement, Leadership, Patient Safety

Industry

Pharmaceutical Manufacturing

Description

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 Job Description 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 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. 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. Qualifications 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 timeframes. 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 Additional Information 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 team? Come join a culture that empowers every person to be the person that makes a difference for rare disease. Why Join Us? We are a global company with over 1,900 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you. We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff. Sobi Culture At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them. As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth. Sobi Location: Switzerland

Responsibilities

This role involves owning the end-to-end lifecycle of Pharmacovigilance Agreements (PVAs), including development, execution, and maintenance, while collaborating globally to ensure compliant pharmacovigilance obligations are embedded in commercial and managed access programs. The manager will oversee collaborations with external partners, lead PVA negotiations, and provide subject matter expertise on evolving PV regulations.