BioTalent
Senior Principal Consultant (Medical) at BioTalent, part of The IN Group
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 role directs safety strategy, operations, and regulatory compliance for oncology drug products across clinical development and commercialisation phases. This leadership position 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 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.
If interested, please apply using the link or reach out to Ella Jobson on +49 8954194957
#J-18808-Ljbffr
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 role directs safety strategy, operations, and regulatory compliance for oncology drug products across clinical development and commercialisation phases. This leadership position 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 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.
If interested, please apply using the link or reach out to Ella Jobson on +49 8954194957
#J-18808-Ljbffr