Senior Global Safety Leader

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. Within Bayer, we\’re changing the way we work— for higher productivity, faster innovation, and better results. We call it Dynamic Shared Ownership (DSO). Learn more about what DSO will mean for you in your new role here https://www.bayer.com/en/strategy/strategy Senior Global Safety Leader The Senior Global Safety Leader is responsible for the patient centered benefit-risk of Bayer pharma products and maintenance of compliance with the Pharmacovigilance regulations of Regulatory Agencies around the globe through the effective and timely completion of PV Assessment activities through product development (starting with phase I) and through life cycle management. This is a senior clinical scientist with deep expertise in key topics in pharmacovigilance (e.g., immunology, gene therapy, cell therapy, Drug-Induced Liver Injury, reproductive toxicity, quantitative signal detection) and clinical medicine, including methods to assess and communicate benefit risk balance, manage and mitigate risk to patient and optimize the use of pharma products in clinical practice. Key Working Relationships PV Benefit-Risk Management Therapeutic Area Group Head PV Pharma Benefit-Risk Management Head Project lead counterparts in MA, CD, RA, HEOR, legal and other relevant business functions Benefit-Risk Management Team (Leader), GPT, MCT and PET Governance Committees, e.g. Safety Review Committee, Global Labeling and Global Safety Committee Key Tasks Provides in-depth expertise on safety and benefit-risk balance topics to the Therapeutic Area Group Head as well as senior level management committees (eg Therapeutic Area Development Committee, Global Safety Committee), to our legal department, to Data Monitoring Committees and to external regulatory agencies. Conducts in-depth assessment of complex safety and benefit-risk topics based on an in-depth knowledge of all phases of clinical development, evidence-based medicine, key pharmacovigilance topics (eg, Drug-Induced Liver Injury – DILI), quantitative signal detection and the wide range of ways to assess, communicate and manage the benefit-risk balance. Represents Bayer on industry consortia focusing on benefit-risk and safety topics. Establishes and maintains an appropriate network of external scientific consultants, and as appropriate, advisory boards to provide guidance to Bayer on key safety topics. In addition, the Senior Global Safety Leader carries out, in a highly autonomous manner, tasks and responsibilities of a Global Safety Leader, as assigned by the Therapeutic Area Group Head. Leads Benefit-Risk Management team and drives implementation of state-of-the art strategies to proactively monitor and assess the benefit-risk balance (starting at D3 – prior to First-In-Man). Ensures that the core benefit-risk assessment (CoBRA) is used as a key document for product positioning, regulatory development and maintenance strategies, medical governance, and benefit-risk management activities. Analyses, on an ongoing basis, all available data from studies, adverse event reporting, medical and scientific information and communication from regulatory agencies. Integrates the information to perform signal detection and assessment. Escalates topics as appropriate to the relevant committees (eg, Safety Review Committee, Global Safety Committee). Responsible for the ongoing benefit-risk assessment of all assigned marketed products. Ensures that the benefit-risk balance is consistently positive, and that when appropriate, risk management activities are diligently and adequately implemented to optimize the safe use of the assigned products. Member of key cross functional teams (eg. Global Project Team, Medical Core Team, Product Evaluation Team) representing PV for all assigned projects or products. Provides high quality and consistent input to these teams to optimize the clinical development and life cycle management. Provides medical assessment of in- and out-licensing opportunities of development projects. Skills and Qualifications MD degree or equivalent (e.g., DO or MB) required. Ten years or more of clinical experience and/or Industry experience, with a focus on patient safety and pharmacovigilance experience. Deep knowledge of key topics in pharmacovigilance is required. Deep knowledge of the specific therapeutic area is strongly preferred. Experience with interactions with major Regulatory Agencies. Ability to interact with expert consultants and Key Opinion Leaders. Deep knowledge of pharmacovigilance relevant regulations. Proven evidence of effective delivery of high-quality safety relevant documents. Knowledge of relevant concepts in epidemiology, statistics and evidence-based medicine. Effectively communicates in written and spoken English. Communicates complex issues in an understandable, effective and relevant manner. Strong influencing skills with the ability to explain and defend a position in the face of opposition. Strategic focus to activities and planning, with proactive planning and prioritization skills. Effective team member. Takes ownership of appropriate issues and appropriately delegates. Effectively applies processes across assigned team. Effectively operates within collaboration model and governance framework of at-arms-length operating subsidiaries. Excellent analytical and problem-solving skills. Ability to provide effective and relevant review of complex documents. Other Failure to comply with drug safety regulations could jeopardize the acquisition or maintenance of EU, USA and other international marketing authority for marketed products, or license to continue clinical development programs. Such events would compromise the safety of patients, our corporate reputation and could result in significant financial losses, directly and through penalties and litigation activities. Your Application: Be You at Bayer where you have the opportunity to be part of a culture influencing Health for all and Hunger for none. To achieve our vision we see reward for all our employees as incredibly important, so here are some of the benefits you will receive as a Bayer employee. What we offer Competitive compensation package consisting of an attractive base salary and annual bonus. Individual bonus can also be granted for top performance awards. 28 days annual leave plus bank holidays Private Healthcare, generous pension scheme and Life Insurance Wellness programs and support Employee discount scheme State of the art offices International career possibilities Flexible and Hybrid working Help with home office equipment Volunteering days Support for professional growth in a wide range of learning and development opportunities We welcome and embrace diversity providing an inclusive working environment The best possible work-life balance is of great importance to us, which is why we support flexible hybrid working model. Bayer welcomes applications from all individuals, regardless of age, disability, gender identity/expression, family status, pregnancy and maternity, race, religion or belief, sex, and sexual orientation. We are committed to treating all applicants fairly and without discrimination. Bayer is committed to providing access and support for all individuals with disabilities and/or long-term conditions – during the application process and beyond. Let us know if there is anything about the recruitment process that you would like to discuss, in particular if there are any changes or adjustments that would make it easier for you to apply please contact HROP_UK@bayer.com . Location: United Kingdom : Berkshire : Reading Division: Pharmaceuticals Reference Code: 838828 #J-18808-Ljbffr