*Sweden Only*
A key client of mine based in the Nordics is looking for an experienced Pharmacovigilance Manager to join the team on a permanent, full-time basis.
Position Overview:
This is a leadership opportunity within a growing biotechnology organization focused on biosimilar development. The role offers strategic and operational oversight of global pharmacovigilance (PV) systems and activities, spanning both clinical and post-marketing settings.
Key Responsibilities:
- Strategic PV Oversight: Lead and participate in the full spectrum of pharmacovigilance activities within the safety function, ensuring excellence in safety governance and execution.
- Global PV System Management: Design, maintain, and enhance a comprehensive global pharmacovigilance system that supports both clinical development and marketed products.
- Cross-Functional Safety Support: Collaborate with internal departments including Clinical Development, Medical Affairs, and Regulatory to align on safety-related objectives and initiatives.
- Stakeholder Coordination: Interface with internal stakeholders and external partners (including CROs and vendors) to ensure compliance, continuity, and high performance across PV operations.
- Safety Oversight: Oversee case management, signal detection, risk management plans, aggregate reporting, and regulatory submissions for both investigational and marketed products.
- Regulatory Compliance: Ensure adherence to global pharmacovigilance legislation and GxP standards and play a key role in audit readiness and health authority inspections.
- Training & Development: Deliver and support internal training programs to promote high standards in PV processes and compliance across teams and collaborators.
Candidate Profile
- Academic Background: Master’s degree (or higher) in pharmacy, medicine, life sciences, or a related discipline.
- Industry Experience: At least 5 years of hands-on pharmacovigilance experience in the pharmaceutical or biotech industry; prior exposure to biosimilars is a significant advantage.
- Technical Competence: Strong command of safety database systems and essential tools such as Microsoft Office, Adobe, SharePoint, electronic signature systems, and document management platforms (e.g., Veeva).
- Regulatory Knowledge: Thorough understanding of global PV requirements and industry guidelines (e.g., ICH, GVP, CIOMS, GCP, 21 CFR).
- Soft Skills: Excellent communication skills in English, both written and verbal. Strong organizational ability, self-direction, and effective prioritization.
- Work Ethic & Culture: Team-oriented mindset with a proactive and results-driven approach. Able to work across diverse cultures and willing to travel as necessary.