Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

Global Safety Leader Oncology MD

Your tasks and responsibilities

The primary responsibilities of this role, Global Safety Leader Oncology MD   are to: 

 

  • Be responsible for the safety assessment activities of assigned products under the supervision of Global Pharmacovigilance Benefit Risk Management (PVBRM) Therapeutic Area Head;
  • Support monitoring the benefit risk profile of assigned portfolio in an ongoing fashion and in accordance with Bayer and Pharmacovigilance (PV) processes;
  • Lead the PV benefit 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, Product Technical Complains (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) fulfill the requirements for signal detection and aggregate report compilation through targeted training;
  • Ensure appropriate clinical safety risk communication and escalation within Bayer to PV Management and the Qualified Person of Pharmacovigilance (QPPV) and Bayer Safety Committees including Safety Review Committee (SRC), Global Safety Committee (GSC), Product Expert Team (PET) and Global Labeling Committee (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 Periodic Safety Update Reports/Periodic Benefit Risk Evaluation Reports (PSUR/PBRERs), Development Safety Update Reports (DSURs), Development Risk Management Plans (DRMPs) and Risk Management Plans (RMPs) (core and EU);
    • Benefit Risk Statements;
    • Safety section of Development Care Safety Information (DCSI) and relevant Position paper and Justification documents;
    • Answers to assigned safety relevant Health Authorities requests and complex Answers to Queries (A2Qs);
    • Safety relevant communications such as Dear Health Care Professional (DHCP) letters and company statements;
  • Liaise with internal and external experts/Key Opinion Leaders (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 Therapeutic Area (TA);
  • Plan and deploy skilled resources against project priorities in consultation with PVBRM TA Head.

     

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:

 

  • M.D. degree or equivalent (e.g., D.O. or M.B.);
  • Two years or more of clinical experience and/or Industry experience;
  • Ability to interact with Key Opinion Leader;
  • 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:

 

  • Focus on patient safety or prior pharmacovigilance experience;
  • Deep knowledge of the specific therapeutic area;
  • Experience with interactions with major Regulatory Agency.

Your application

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

Bayer is an Equal Opportunity Employer/Disabled/Veterans

 

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

 

Country: United States
Location: NJ-Whippany