Global Head of Pharmacovigilance

BioTalent are delighted to partner with a rapidly growing biotech client, dedicated to transforming cancer treatment, currently hiring for a Global Head of Pharmacovigilance.

This is a strategic leadership role responsible for guiding safety strategy, ensuring compliance, and driving successful trial conduct for company assets across all stages of development. This be responsible for directing safety strategy, operations, and regulatory compliance for oncology drug products across clinical development and commercialisation phases. This leadership role is central to ensuring safe, compliant, and successful oncology drug development and to maximising patient safety from clinical trials to post-marketing surveillance.

This position will report to the Chief Medical Officer and either work on a hybrid basis from the company office in Germany or on a remote basis.

Your mission

• Develop and execute the overall drug safety and pharmacovigilance (PV) strategy aligned with company and global regulatory requirements, especially for oncology assets.
• Oversee safety surveillance, signal detection, risk assessment, and risk mitigation for investigational and marketed oncology products.
• Ensure compliance with international PV regulations (FDA, EMA, ICH), SOPs, and best industry practices.
• Lead and build high-performing PV teams, including medical safety
• experts and regulatory specialists, fostering a collaborative and high-performance culture.
• Medical oversight of safety data, including the review of case safety reports (SAEs, SUSARs) and aggregate analyses.
• Establish and maintain risk management plans, safety monitoring plans, data exchange agreements, and readiness for health authority inspections.
• Represent the company in safety-related interactions with regulatory agencies, partners, and external stakeholders.
• Collaborate cross-functionally with clinical development, regulatory, medical affairs, and other teams integrating safety across the product lifecycle.

Ideally, you will have :

If interested, please apply using the link or reach out to Ella Jobson on +49 8954194957