YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Director Global Safety Leader Medical Doctor - Oncology, are to: 

• Be responsible for the safety assessment activities of assigned products under the supervision of Global PVRM Therapeutic Area Head;
• Monitor the benefit risk profile of assigned portfolio in an ongoing fashion and in accordance with BSP and GPV processes;
• Lead the PV risk management processes including chairing Safety Management teams;
• Identify, prioritize and analyze clinical safety signals;
• Perform ongoing review of emerging safety data from various sources including single case reports, PTCs and published literature and reports from partner functions;
• Work with the Systems and Operations teams to develop and continuously maintain and improve effective systems to ensure single cases (including PTCs and other relevant reports) and fulfill the requirements for signal detection and aggregate report compilation through targeted training;
• Ensure appropriate clinical safety risk communication and escalation within BSP to GPV Management and QPPV and BSP Safety 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 and timely delivery of aggregate reports including PSUR/PBRERs, DSURs, DRMPs and RMPs (core and EU), benefit Risk Statements, safety section of DCSI and relevant position paper and justification documents;
• Answer to assigned safety relevant HAs requests and complex A2Qs;
• Provide safety relevant communications such as DHCP letters and company statements;
• Liaise with internal and external experts /KOLs to obtain specialized medical expertise as appropriate;
• Provide high quality and consistent input to development teams and product teams to support clinical development and life cycle management;
• Provide medical safety oversight of clinical study data in the context of the medical review process for clinical studies;
• Interact with license partners to support the Global license officer in the preparation and maintenance of PV agreements;
• Perform effective due diligence activities within the assigned TA;
• Plan and deploy skilled resources against project priorities in consultation with GPV-RM TA Head;
• Support GPV-RM TA Head in strategic decision making.
   

WHO YOU ARE

Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• Medical degree or equivalent (e.g. D.O. or M.B.);
• At least four years or more of clinical experience and/or industry experience;
• Ability to interact with Key Opinion Leaders;
• Good knowledge of pharmacovigilance relevant regulations;
• Proven evidence of effective delivery of high-quality safety relevant documents;
• Knowledge of relevant concepts in epidemiology and statistics;
• 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;
• Technical expertise in patient safety gained from experience in a PV or a clinical background, including understanding of adverse events, adverse drug reactions, reporting systems, pharmacologic principles behind these adverse events, and measures to ensure patient safety;
• Excellent analytical and problem-solving skills;
•  Ability to provide effective and relevant review of complex documents.

Preferred Qualifications:
 

• Clinical experience and/or industry experience, with a focus on patient safety or prior pharmacovigilance experience;
• Deep knowledge of the Oncology therapeutic area;
• Experience with interactions with major Regulatory Agency.