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
* 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 (e.g. 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 (e.g., 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.
* 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 (e.g. Safety Review Committee, Global Safety Committee). Produces high quality aggregate reports (e.g. PSUR/PBRER) and responses to regulatory queries.
* 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 (e.g. 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.
* 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.
* 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.
What we offer
* Competitive compensation package consisting of an attractive base salary and annual bonus.
* 28 days annual leave plus bank holidays.
* Private Healthcare, generous pension scheme and Life Insurance.
* Wellness programs and support.
* State of the art offices.
* International career possibilities.
* Flexible and Hybrid working.
* Help with home office equipment.
* Support for professional growth in a wide range of learning and development opportunities.
* We welcome and embrace diversity providing an inclusive working environment.
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