Senior Benefits Risk Management Lead

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. Bayer is an organisation where decisions are made together and where innovation cycles are in 90 days sprints. Our operating model (Dynamic Shared Ownership (we call it DSO) is a reimagined way of operating a multinational company which moves at speed and scale with the goal of delivering on our vision. Being part of #TeamBayer means that you are part of our vision and of our future – delivering to our farmers, patients, and consumers. https://www.bayer.com/en/strategy/strateg y

As the Senior Benefit Risk Management (BRM) Lead /Oncology you are responsible for leading and close collaborating with product teams of Global Safety Leaders (GSLs) and other PV BRM experts.

Ensuring patient safety for Bayer’s oncology product portfolio throughout the product lifecycle (pre-clinical to Phase 4 and post-marketing, routine and submission PV activities) and compliance with health authority pharmacovigilance (PV) regulations around the globe through the effective and timely completion of PV assessment activities.

This is a senior clinical scientist position with deep expertise in key topics in;

• Pharmacovigilance (e.g. drug-induced liver injury (DILI), reproductive toxicity, quantitative signal detection etc.)
• Oncology drug development and clinical medicine, including methods to assess and communicate benefit risk balance, manage and mitigate risk to patients and optimize the safe use of pharma products in clinical practice
  
  

KEY WORKING RELATIONS

Leadership level interface with Global Project Management, Drug Development, Clinical Sciences, Clinical Development, Medical Affairs, Regulatory Affairs and Business Development.

Direct presentations or oversight of presentations to governance committees such as GSC, GLC and other senior management committees.

Representation where needed with health authorities and external scientific bodies.

YOUR TASKS AND RESPONISIBILITIES

• Leading product groups responsible for ongoing BRM and/or leading BRM activities for products of strategic importance by providing in-depth assessment of complex safety and benefit-risk topics based on an in-depth knowledge of oncology clinical development, evidence-based medicine, key pharmacovigilance topics (e.g. DILI), quantitative signal detection and the wide range of ways to assess, communicate and manage the benefit-risk balance.
• Responsible for the effective performance for the product/product group of clinical signal detection, evaluation and benefit risk management including:
• Monitor and manage the benefit risk profile of assigned product/product group in an ongoing fashion by leading cross functional Safety Management and Benefit-Risk Management teams and implementation of state-of-the art strategies to proactively monitor and assess the benefit-risk balance.
• Identify, prioritize and analyze clinical safety signals.
• Lead the patient benefit risk management processes through Safety Management Teams
• Ensure appropriate clinical safety risk communication and escalation within Bayer Pharma to PV Management and QPPV and committees including SRC, GSC, PET and GLC.
• Produce high quality aggregate reports and responses to regulatory queries.
• Ensure adequate labeling of safety related information.
• Ensure effective due diligence activities.
• Work with the Systems and Operations teams to develop and continuously maintain and improve effective systems to ensure single cases (inc PTCs and other relevant reports) are of submission quality and fulfill the requirements for signal detection and aggregate report compilation.

INTERESTED IN THIS POSITION?

Are you looking for a new challenge? Apply online by sending us your resume and cover letter. Do you have a question or do you want to learn more about the position? You can always contact Sandra de Klerk via Sandra.deKlerk.ext@bayer.com

Application Period:5th Undefined Reference Code: 858206

Division: Pharmaceuticals Location: United Kingdom : Berkshire : Reading

Functional Area: Medical Affairs & Pharmacovigilance Position Grade: VS 3

Employment Type: Regular Work Time: Full Time

Contact Us

Address Telephone E-Mail

400 South Oak Way, Green Park, Reading, Berkshire RG2 6AD UK

(+44) 118 206 3333

hrop_uk@bayer.com