Global Safety Officer Oncology in Bridgewater, NJ at Apex Life Sciences

Date Posted: 8/29/2018

Job Snapshot

Job Description


Responsibilities:

  • Provide PV and risk management expertise to internal and external customers
  • 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.
  • 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.
  • 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.
  • 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.
  • 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:
  • M.D. or related degree required
  • 5+ years total experience in international pharmacovigilance
  • 7-10 years preferred Oncology experience
  • Experience in a Clinical development environment as a Clinical physician a must 
  • Board Certified/Board eligible, or equivalent desired
  • 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
  • Strategically Motivated required
  • Hematology and Oncology experience highly preferred

**For immediate consideration, please email your updated resume to ksavas@apexlifesciences.com with 'Global Safety Officer Oncology' in the subject line.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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