Global Head of Drug and Patient Safety

Meet Life Sciences; München; Vor Ort; EUR 120.000 - 160.000; Vollzeit

Zusammenfassung

A global biotechnology organization is seeking a Head of Global Drug Safety to lead its pharmacovigilance strategy in oncology. This senior role focuses on regulatory compliance and risk management for post-approval oncology products. The ideal candidate will possess extensive experience in drug safety, have a strong background in oncology, and demonstrate expertise in regulatory standards. The position is based in Munich, offering an opportunity to shape safety strategies and ensure patient protection in innovative therapies.

Qualifikationen

• Extensive experience in post-approval drug safety and pharmacovigilance.
• Experience across both small molecules and biologics.
• Strong background in oncology or specialized therapeutic area.

Aufgaben

• Lead the global pharmacovigilance and drug safety strategy.
• Build and lead a high-performing global drug safety organization.
• Ensure compliance with international regulatory requirements.

Kenntnisse

Leadership

Pharmacovigilance

Regulatory compliance

Oncology expertise

Strategic thinking

Ausbildung

Qualified MD or equivalent medical degree

Jobbeschreibung

About the Job

Our client is a global, patient-focused biotechnology organisation dedicated to advancing innovative oncology therapies that improve outcomes for people living with cancer.

Position Summary

The Head of Global Drug Safety is a senior leadership role responsible for shaping and executing the company’s worldwide pharmacovigilance strategy, with a strong emphasis on post-approval safety and risk management for oncology products. The Head ensures robust regulatory compliance, strengthens patient protection, and drives scientific and operational innovation throughout the post-approval lifecycle.

As a key member of the governance leadership team, the Vice President plays an essential role in advancing the global safety strategy and maintaining the highest standards of patient safety. While clinical safety support is not the primary focus, the role may occasionally contribute to clinical development activities when relevant.

Roles and Responsibilities

Global Drug Safety Management

• Lead the global pharmacovigilance and drug safety strategy for all post-approval oncology products, including safety support for late-stage assets approaching regulatory submission or commercial launch.
• Establish and maintain comprehensive safety surveillance systems to detect, assess, and report adverse events.
• Ensure compliance with international regulatory requirements (e.g., EMA, FDA) and guidelines (ICH, GVP) governing safety surveillance and risk management.
• Provide expert safety input for risk‑management plans and post‑authorisation safety activities.
• Serve as the primary safety contact during regulatory authority interactions.
• Oversee inspection and GVP audit readiness.

Team Leadership & Development

• Build and lead a high‑performing global drug safety organisation, promoting excellence, collaboration and continuous improvement.
• Mentor and develop team members to support capability growth and long‑term performance.
• Lead recruitment efforts aligned with business and portfolio expansion.
• Partner with senior leadership to drive organisational evolution and contribute to company‑wide strategic initiatives.
• Represent the company at key scientific, regulatory and industry forums to expand visibility and strengthen external partnerships.

Regulatory & Compliance

• Ensure all safety and pharmacovigilance activities meet global regulatory requirements and internal standards.
• Collaborate with Regulatory Affairs on safety‑related submissions, PSURs and labelling updates for marketed and late‑stage products.
• Stay current with emerging global regulations and scientific advancements relevant to oncology safety.
• Provide strategic direction on regulatory interactions and inspection readiness related to safety and benefit‑risk management.

Risk Management & Decision‑Making

• Deliver expert benefit‑risk assessments to support filings, lifecycle management and commercial decisions.
• Implement risk‑mitigation strategies in response to emerging safety signals across the oncology portfolio.
• Play a critical leadership role in governance forums guiding safety, labelling and benefit‑risk strategy.
• Partner with cross‑functional colleagues to drive informed, data‑driven safety decisions.

Business Development & Asset Due Diligence

• Provide safety expertise to support business development activities, including evaluations of potential in‑licensing, co‑development or acquisition opportunities.
• Conduct due diligence on new oncology assets, reviewing safety profiles and regulatory considerations.
• Identify risks and opportunities associated with external assets and partnerships.

Requirements

Education and Qualifications

• Qualified MD or equivalent medical degree (e.g., MBBS, MBChB, MBBCh, BMBS, BMBCh).

Professional Experience

• Extensive experience in post‑approval drug safety and pharmacovigilance within the biopharmaceutical industry, including leadership of global teams and safety strategies.
• Experience across both small molecules and biologics.
• Strong background in oncology (preferred) or another specialised therapeutic area.
• Demonstrated global experience across multiple regulatory regions (Europe, North America, Asia).

Experience and Skills

• Deep understanding of global safety regulations and standards (EMA, FDA, ICH, GVP).
• Proven success leading cross‑functional teams and external collaborations, including CRO partnerships and interactions with key opinion leaders.
• Strong leadership, communication and decision‑making skills in complex, fast‑paced environments.
• Strategic mindset with a commitment to innovation and scientific excellence.

Other Skills / Attributes

• Passion for advancing oncology therapies and improving patient outcomes.
• Strong people‑leadership and team‑development capabilities.
• Strategic thinking and analytical problem‑solving.
• Expertise in regulatory compliance.
• Effective communicator and collaborative partner across functions.