Sobi - Swedish Orphan Biovitrum AB (publ)

Senior Pharmacovigilance Licensing Manager

Sobi - Swedish Orphan Biovitrum AB (publ)

full-time

Posted on:

Location Type: Remote

Location: United Kingdom

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Job Level

Senior

About the role

  • 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

Requirements

  • 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
Benefits
  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
pharmacovigilanceregulatory affairsquality assurancesafety alliance managementcollaboration managementnegotiationproject managementdata exchangerisk managementcompliance
Soft Skills
communicationproblem-solvingorganizational skillsleadershipteamworkstrategic thinkingprocess improvementtrainingadaptabilitymotivation