Pharmacovigilance Licensing Manager at Sobi

Stockholm, , Sweden -

Full Time

Start Date

Immediate

Expiry Date

17 Sep, 26

Salary

0.0

Posted On

19 Jun, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Pharmacovigilance Agreements, Regulatory Compliance, Negotiation, Patient Safety, Alliance Management, Cross-functional Collaboration, Risk Mitigation, CAPA Plans, Audit Support, Life Sciences

Industry

Pharmaceutical Manufacturing

Description

Company Description Sobi is an international biopharmaceutical company, dedicated to providing access to innovative treatments that transform life for people with rare diseases in the areas of haematology, immunology and specialty care. With our head office in Stockholm, Sweden, Sobi also has premises in Basel, Switzerland. You can find more information about Sobi at www.sobi.com. 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. Additional Information 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. Sobi Location: Sweden

Responsibilities

Manage the end-to-end lifecycle of Pharmacovigilance Agreements (PVAs) and oversee strategic collaborations with external business partners. Provide expert advice on regulatory compliance and ensure alignment between internal safety functions and global agreements.