Pharmacovigilance Manager

About the role

Biologit is seeking a Pharmacovigilance Manager to lead its drug safety, clinical safety and risk management activities. The role ensures that all pharmacovigilance operations are performed in full compliance with global and local regulations while supporting the company’s mission to improve patient safety through automation and AI‑driven literature review.

Key responsibilities

• Oversee and manage all pharmacovigilance activities performed by Biologit for sponsors, applicants and marketing authorisation holders.
• Ensure compliance with legal and regulatory requirements, including FDA, EMA, GDPR and ISO 27001 standards.
• Represent the pharmacovigilance function in internal and external meetings and contribute to operational strategy.
• Support health authority inspections and internal/external audits focused on pharmacovigilance.
• Maintain up‑to‑date global knowledge of pharmacovigilance regulations and identify process gaps.
• Develop, review and maintain policies, SOPs, guidelines, templates and plans.
• Oversee CAPA creation, assignment, implementation and closure related to pharmacovigilance.
• Interact with sponsors, applicants, marketing authorisation holders and partners.
• Motivate and develop the pharmacovigilance team to foster engagement and high performance.

Required profile

• Proven experience in pharmacovigilance, drug safety or clinical safety management.
• Strong understanding of global regulatory frameworks (FDA, EMA, GxP, GDPR, EU AI Act).
• Demonstrated ability to lead and develop multidisciplinary teams.
• Excellent communication skills for internal and external stakeholder engagement.
• Experience supporting health authority inspections and audits.

Required skills

• In‑depth knowledge of pharmacovigilance processes and regulations.
• Familiarity with ISO 27001, GxP compliance and data protection standards.
• Ability to draft and maintain SOPs, policies and risk management documentation.