Global head of pharmacovigilance

BioTalent Ltd; Thüringen; Hybrid; EUR 80.000 - 100.000; Vollzeit

Zusammenfassung

A leading biotechnology company in Germany is seeking a strategic leader for drug safety and pharmacovigilance in oncology. The role involves guiding safety strategy, ensuring compliance, and overseeing trial conduct. The ideal candidate will have extensive experience in drug safety, particularly with oncology products, and a medical degree. This position offers the flexibility of hybrid or remote work.

Qualifikationen

• 12-15+ years of experience in drug safety/pharmacovigilance.
• At least 5 years at a senior leadership level in biotech and pharma.
• Fluency in English required.

Aufgaben

• Direct safety strategy and compliance across drug development.
• Oversee safety surveillance and risk mitigation for oncology products.
• Lead high-performing pharmacovigilance teams.

Kenntnisse

Drug safety/pharmacovigilance

Leadership

Oncology expertise

Communication

Strategic decision-making

Ausbildung

Medical degree (MD, MBBS, DO)

Tools

Safety databases (e.g., Argus)

Coding dictionaries (MedDRA)

Jobbeschreibung

Overview

Tubulis is dedicated to developing novel, effective, and safe therapies for the treatment of cancer — one of the most pressing challenges in modern medicine. Our mission is to become a leading company in targeted therapeutics and antibody–drug conjugates (ADCs). With a passionate team, proprietary technologies, and innovative therapeutic concepts, we are ushering in a new era in the fight against cancer.

Join a multidisciplinary, highly focused group working to deliver promising ADCs to patients with solid and haematological cancers.

Role and responsibilities

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 will 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:

• A medical degree (MD, MBBS, DO) or equivalent clinical degree.
• 12–15+ years of experience in drug safety/pharmacovigilance with at least 5 years at a senior leadership level in biotech and pharma.
• Oncology experience is required.
• Experience with Antibody Drug Conjugates (ADCs) is a strong plus.
• In-depth knowledge of global PV regulations and experience with safety and efficacy submissions (IND, BLA, NDA, MAA).
• Experience with risk management plans, signal detection, aggregate safety data review, and case management.
• History of building, leading, and mentoring multidisciplinary teams.
• Familiarity with major safety databases (e.g., Argus), coding dictionaries (MedDRA), and digital safety systems.
• Outstanding communication skills and proven ability to influence, collaborate, and present safety strategy to senior leaders and regulatory authorities.
• Strategic decision-making abilities and the capacity to oversee budgets, resources, and department objectives in a dynamic environment.
• Fluency in English.