Job Description

At Bayer we\'re visionaries, driven to solve the world\'s toughest challenges and striving for a world where ,Health for all, Hunger for none\' is no longer a dream, but a real possibility. We\'re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining \'impossible\'. There are so many reasons to join us. If you\'re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there\'s only one choice.

Senior Global Safety Leader Rare Diseases Cell & Gene Therapy

At Bayer Pharmaceuticals, we are dedicated to revolutionizing the healthcare industry through our cutting-edge research, development, and marketing of specialty-focused innovative medicines. Our mission is to provide significant clinical benefit and value to patients in therapeutic areas such as cardiology, oncology, gynecology, hematology, and ophthalmology. With nearly 50 ongoing development projects in clinical trials, we are a global leader in research-based pharmaceuticals.

YOUR TASKS AND RESPONSIBILITIES

• Lead the Benefit-Risk Management team, implementing state-of-the-art strategies to proactively monitor and assess the benefit-risk balance from early stages of clinical development
• Provide expert guidance on safety and benefit-risk balance to the Therapeutic Area Group Head, senior management committees, and external regulatory agencies
• Conduct comprehensive assessments of complex safety and benefit-risk topics using your extensive knowledge of clinical development, evidence-based medicine, and key pharmacovigilance areas
• Analyze available data from studies, adverse event reporting, and regulatory communication to detect and assess signals, providing high-quality aggregate reports and responses to regulatory queries
• Ensure ongoing benefit-risk assessment of assigned marketed products and implement risk management activities to optimize their safe use
• Represent Bayer in industry consortia focusing on benefit-risk and safety, while building and maintaining a strong network of external scientific consultants and advisory boards
• Collaborate with cross-functional teams to provide input on patient safety and benefit-risk balance, optimizing clinical development and life cycle management

WHO YOU ARE

• MD degree or equivalent (e.g., DO or MB) required
• Long-term clinical or industry experience, with a focus on patient safety and pharmacovigilance across the life cycle, including clinical development
• Deep knowledge of key pharmacovigilance topics and a strong understanding of the specific therapeutic area are essential
• Experience with interactions with major regulatory agencies
• Ability to engage with expert consultants and Key Opinion Leaders
• Familiarity with pharmacovigilance regulations and evidence-based medicine concepts
• Strong influencing skills and the ability to defend positions effectively
• Strategic mindset with proactive planning and prioritization abilities
• Effective team player who takes ownership and delegates appropriately
• Proficient in operating within a collaboration model and governance framework
• Outstanding analytical, problem-solving, and document review skills

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Location:

United Kingdom : Berkshire : Reading

Division:

Pharmaceuticals

Reference Code:

794347

Bayer