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.

TA Head GPV Risk Management MD- Oncology

Your tasks and responsibilities

The primary responsibilities of this role, Director GPV Risk Management MD, are to: 

  • Responsible for the effective performance within the TAG of clinical signal detection, evaluation and risk management including: o Monitor the benefit risk profile of assigned portfolio in an ongoing fashion and in accordance with BSP and GPV processes;
  •  Identify, prioritize and analyze clinical safety signals;
  • Lead the patient safety risk management processes through Safety Management Teams;
  • 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 of high quality aggregate reports and responses to regulatory queries;
  • Ensure adequate labeling of safety related information;
  • Ensure effective due diligence activ1t1es within the assigned TA;
  • Work with the Systems and Operations teams to develop and continuously maintain and improve effective systems to ensure single cases (me PTCs and other relevant reports) are of submission quality and fulfill the requirements for signal detection and aggregate report compilation;
  • Provide the strategic leadership for the TAG;
  • Provide high quality and consistent input to development teams and product teams to support clinical development and life cycle management;
  • Plan and deploy skilled resources against project priorities;
  • Contribute to development of budget and work within those allocated constraints throughout the fiscal cycle;
  • Recruitment, on-boarding, training and development, performance management, and succession planning within the TAG;
  • Maintain an environment of continuous improvement  within  the team and contribute to continuous improvement initiatives across GPV;
  • Support the strategic goals of GPV;
  • Support the GPV Leadership team in strategic decision making;
  • Ensure product and TA level considerations are addressed in decision making;
  • Support and lead process improvement and implementation across BSP;
  • Work collaboratively with other TA heads to ensure consistency of approach across TAGs;
  • Maintain effective business relationships across the business unit to support the implementation of BSP clinical safety standards.
     
     
     

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:

 

  • MD degree required, with 5 or more years of pharmacovigilance experience and 2 years of clinical experience or relevant experience;
  • Appropriate experience with Regulatory Agency and KOL interaction;
  • Proven history of effective leadership within a matrix organization;
  • Experience with the GPV "Tool box" regarding databases/ other IT/ Coding systems etc;
  • Excellent knowledge of pharmacovigilance relevant regulation;
  • Proven evidence of effective delivery of high quality safety relevant documents;
  • Knowledge of relevant concepts in data management and systems , pharmacoep1demiology and statistics;
  • 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;
  • Effectively communicates in written and spoken English;
  • Effective Team Leader and manager of a team of highly qualified individual contributors;
  • Team-orientated, recognizing the value of and utilizing diversity;
  • Strategic focus to activities and planning, with proactive planning and prioritization skill;
  • Effective team member. Takes ownership of appropriate issues and appropriately delegates;
  • Effectively applies processes across assigned team.

 

 

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
Functional Area: [sap_fa_30]
Entry Level: 5