Senior Global Safety Leader

 

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 PV Strategy activities throughout product/s lifecycle. This is a senior clinical scientist with deep expertise in clinical medicine, various topics in clinical pharmacovigilance (eg skin, liver, cardiac and reproductive toxicity), topics specific to oncology (oncology study designs/end points/dose optimization, oncology specific safety topics)  and pharmacovigilance strategy and methods, including safety surveillance, risk monitoring, risk assessment, risk communication, benefit risk management with the goal of mitigating risk to patients and optimize the use of medicinal products in clinical practice. Demonstrated ability to lead and collaborate within complex global organization, commitment to mentorship and professional growth of team members is highly desirable.

 

 

YOUR TASKS AND RESPONSBILITIES

 

The primary responsibilities of the Senior Global Safety Leader are to:

 

• 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), internal cross-functional groups and functions, external Data Monitoring Committees, Regulatory agencies and other stakeholders;
• Actively contributes into developing creative and efficient methods and approaches in support of strategic Global MA/PV objectives;
• 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. These include but not limited to:
  • Represents PV in key cross functional internal teams (eg, Global Project Team, Medical Core Team, Product Evaluation Team) and in interactions with external bodies (Advisory boards, Health Authorities, IDMCs, etc) for assigned projects. Provides high quality and consistent input to these teams to optimize the clinical development and life cycle management. 
  • Leads Benefit-Risk Management team and drives implementation of state-of-the art strategies to proactively monitor and assess the benefit-risk balance effectively applying relevant regulations and evolving industry practices. 
  • Conducts in-depth assessment of complex safety and benefit-risk topics based on an in-depth knowledge of all phases of oncology clinical development, evidence-based medicine, clinical pharmacovigilance topics, quantitative and qualitative signal detection and the wide range of ways to assess, communicate and manage the benefit-risk balance.
  • Leads submission related activities and is accountable for the content and quality of safety related activities and deliverables. 
  • Produces high quality safety related documents, including aggregate reports, RMPs, regulatory responses. Responsible and accountable for safety related sections of documents throughout the product life cycle (i.e protocols, IBs, ICFs, CCDS, prescribing information, etc)
  • Provides medical assessment of in- and out-licensing opportunities of development projects.
  • Represents Bayer on industry consortia focusing on benefit-risk and safety topics (eg, CIRS, IQ-DILI). Establishes and maintains an appropriate network of external scientifi