Director Global Pharmacovigilance Risk Management

posted in: Careers, Physicians | 0

The primary responsibilities of this role, Director Global Pharmacovigilance Risk Management MD, Oncology are to:


•Effectively perform within the TAG (Therapeutic Area Group) of clinical signal detection, evaluation and risk management
•Monitor the benefit risk profile of assigned portfolio in an ongoing fashion and in accordance with  Global Pharmacovigilance (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 to GPV Management and Qualified Person of Pharmacovigilance (QPPV) and Safety Committees including Safety Review Committee (SRC), Global Safety Committee (GSC), Product Evaluation Team (PET) and Global Labeling Committee (GLC)
•Produce high quality aggregate reports and respond to regulatory queries
•Ensure adequate labeling of safety related information
•Ensure effective due diligence activities within the assigned Therapeutic Area (TA)
•Work with the Systems and Operations teams to develop and continuously maintain and improve effective systems to ensure that single cases (including PTCs (Product Technical Complaints) and other relevant reports) are of submission quality
•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 the development of a 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 
•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 clinical safety standards.

 

  • M.D. degree, with five (5) or more years of pharmacovigilance experience and two (2) years of clinical experience or relevant experience
  • Appropriate experience with Regulatory Agency and Key Opinion Leaders (KOL) interactions
  • 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 regulations

qualified candidates should email resume/CV to jobs@tseworldwide.com