Senior Global Safety Leader Rare Disease Cell - Reading, United Kingdom - Bayer

Bayer

Verified Company

Reading, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

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

WHO YOU ARE

MD degree or equivalent (e.g., DO or MB) required
Longterm 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 evidencebased 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, problemsolving, and document review skills