Global Safety Leader- Oncology

The PV Risk Management Leader leads a team of PV Risk Management Experts within the  Oncology Therapeutic Area of the Global PV Risk Management function. The PV Risk Management Leader ensures patient safety of BSP products and maintenance of compliance with the Pharmacovigilance regulations of Regulatory Agencies around the globe through the effective and timely completion of GPV Assessment activities through product development product maintenance and life cycle management. Responsible for the safety assessment activities of assigned products under the supervision of Global PVRM TAH, including:

  • 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
  • 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 (inc PTCs and other relevant reports) are of submission quality 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
  • Perform effective due diligence activities within oncology Ensure effective and timely delivery of:
  • Aggregate reports including PSURs, ASRs and RMPs
  • Safety section of DCSI and relevant Position paper and Justification documents
  • Answers to assigned safety relevant HAs requests and complex A2Qs
  • Safety relevant communications such as DHCP letters and company statements

 

Your qualifications

  • MD degree required, with 2 or more years of pharmacovigilance experience and 2 years of clinical experience.  Oncology experience is preferred.
  • Appropriate experience with Regulatory Agency and KOL interactions.
  • Proven history of effective leadership within a matrix organization Competencies:
  • Good knowledge of pharmacovigilance relevant regulations and BSP standards. Proven evidence of effective delivery of high quality safety relevant documents
  • Knowledge of relevant concepts in data management and systems , pharmacoepidemiology and statistics
  • Effective Communicator
  • Communicates complex issues in an understandable, effective and relevant manner.
  • Communication delivery is appropriate for audience.
  • Strong influencing skills with the ability to explain and defend a position in the face of opposition.
  • Effective Team Leader and manage 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 skills
  • Effective team member. Takes ownership of appropriate issues and appropriately delegates
  • Effectively applies processes across assigned team
  • Technical expertise in pharmacovigilance and clinical safety
  • Excellent analytical and problem solving skills
  • Provide effective and relevant review of complex documents
  • Knowledge of relevant legislations and guidelines
  • Experience with the GPV “Tool box” regarding databases/ other IT/ Coding systems, etc.