Director Global Patient Safety Oncology (MD) in Bridgewater, NJ at Apex Life Sciences

Date Posted: 5/8/2018

Job Snapshot

Job Description


Duties:   Internal & External Safety Expert:
  • Provide PV and risk management expertise to internal and external customers
  • Safety expert for product
  • Maintain knowledge of product, product environment, and recent literature.
  • Maintain PV expertise, and understanding of international safety regulations and guidelines.
  • Lead cross functional Safety Management Teams (SMTs) and GPE internal -Safety Analysis Teams (SATs).
  • Communicate with and represent PV position within project/product teams, with external partners, key opinion leaders, and Health Authorities, and during internal and external negotiations.
  • Provide strategic and proactive safety input into development plans.
  • Support due diligence activities and pharmacovigilance agreements.

Signal Detection and Assessment:
  • Responsible for signal detection and analysis
  • Collaborate with Center of Excellence for Signal Detection and Data Mining and -Safety Epidemiology group.
  • Identify and implement proactive safety analysis strategies to further define the safety profile.
  • Lead aggregate safety data review activities and coordinate safety surveillance activities.


Risk Assessment/Risk Management/ Benefit-Risk Assessment:
  • Provide proactive risk assessment
  • Co-lead benefit-risk assessment with other relevant functions.
  • Develop risk management strategies and plans and monitor effectiveness.
  • Collaborate with Center of Excellence for Risk Management and Safety Epidemiology.

Submission Activities:
  • Represent safety position in cross functional submission teams.
  • Ensure generation, consistency, and quality of safety sections in submission documents.
  • Write responses or contributions to health authorities.
  • Support preparation and conduct of Advisory Committee meetings.

Report Writing:
  • Document, coordinate, review and validate Periodic reports, e.g.
  • RMP update, IND Annual Report, Annual Safety Report/Development Safety Update Report, -Periodic Safety Update Report.
  • Serve as the medical safety expert to the GPE Periodic Reports group for assigned projects and products.
Skills:
  • Providing product safety leadership within project teams having multiple and at times competing priorities and timelines Championing the GPE position within a large and complex organization.
  • Determining the appropriate risk minimization and mitigation measures in light of -B/R assessment in coordination with different parties.
  • Addressing internal and external customer queries, including those from Health Authorities, in a rapid and effective Manner and within appropriate timelines.
  • The above challenges are effectively managed through strong leadership and communication skills paired with an assertive yet collaborative approach, a high level of medical and scientific. 
  • Decision Making Authority: Identify potential signals/issues of pharmacovigilance and evaluate product safety. Recommend/discuss and coordinate appropriate course of action. Ask project/product team for necessary amendments, labelling modifications/variations Lead SMT and SAT. Approve safety regulatory and clinical documents including submission, transversal and primary GPE documents as per SOP
  • Information/Decisions: Transmission of any decision with impact on Study Conduct (e.g. Clinical Hold) Transmission of any safety concerns for which GSO is informed (e.g. Health -Authority restriction/decision)
  Qualifications: 
  • M.D. Degree REQUIRED
  • Minimum 10 years total experience in international pharmacovigilance
  • Board Certified/Board eligible, or equivalent
  • Excellent clinical judgment
  • Capability to synthesize and critically analyze data from multiple sources
  • Ability to communicate complex clinical issues and analysis orally and in writing
  • Able to develop and document sound risk assessment
  • Demonstrates initiative and capacity to work under pressure
  • Demonstrates leadership within cross-functional team
  • Clinical development environment as a Clinical physician
  • MUST Strategically Motivated