Global Safety Leader (MD) in Women’s Health( Associate Director/Director level )

Location – New Jersey

Job Description:

 

  • The Global Safety Leader MD provides medical safety expertise, state of the art pharmacovigilance, and safety risk management in women’s health (both marketed and in development).The Global Safety Leader ensures patient safety of Bayer Healthcare 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 Therapeutic Area Head, including:
  • 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) 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
  • Answers to assigned safety relevant HAs requests and complex A2Qs
  • 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 Women’s Health
  • Plan and deploy skilled resources against project priorities in consultation with GPV-RM TA Head
  • Support GPV-RM TA Head in strategic decision making

 

The selected candidate is required to possess the following:

 

  • MD degree or equivalent (eg, DO or MB) required.
  • Two years or more of clinical experience as well as at least 2 years of pharmacovigilance experience, or overall equivalent experience profile.
  • Appropriate experience with Regulatory Agency and KOL interactions.
  • Good knowledge of pharmacovigilance relevant regulations and BHC standards.

• Proven evidence of effective delivery of high quality safety relevant documents.

  • Knowledge of relevant concepts in data management and systems , pharmacoepidemiology 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 pharmacovigilance and clinical safety.
  • Excellent analytical and problem solving skills.
  • Provide effective and relevant review of complex documents.
  • Experience with the GPV “Tool box” regarding databases/ other IT/ Coding systems.