Global Safety Officer

Waltham, MA

Posted: 06/28/2019 Industry: Biotech/R&D/Science Job Number: 49181


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

  • Ongoing assessment of the safety status of the product
  • Review, preparation, contribution and/or approval of clinical development documents including clinical development plans, SAPs, study protocols, investigator brochures, data monitoring plans, study reports, integrated summary of safety, summary of clinical safety, and labeling
  • Review, preparation, and/or contribution to questions from health authorities, ethics committees, IRBs, external partners
  • Management of product safety alerts
  • Ensuring the GPE position is well articulated to and understood by its internal and external customers
  • Establishment of credibility of GSO function and of GPE

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

  • Signal detection and analysis
  • Development of safety action plans and implementation, as appropriate
  • Enable effective development of product safety
  • Enable appropriate risk management
  • Enable up-to-date risk communication (e.g. labeling)

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

  • Optimization of the product benefit risk profile
  • Development of REMS, Risk Management and Development Risk Management plans
  • Identification and implementation of risk mitigation or other corrective actions as necessary
  • Regulatory compliance
  • Monitoring of risk mitigation tool effectiveness and adjustment of strategy, as needed

  • Excellent clinical judgment
  • Excellent communication skills – written and verbal; fluent in English
  • 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 environment
  • Excellent teamwork and interpersonal skills are required

  • M.D. Degree or degree in pharmacy, biological sciences or related disciplines.
  • For MD, Board Certified/Board eligible, or equivalent, is preferred; For other degrees, advanced post-graduate qualifications e.g. Master or PhD are preferred.
  • For M.D., minimum 3 years' and for other degrees, minimum 5 years' total experience in international pharmacovigilance, or equivalent relevant industry experience (e.g. clinical development) with relevant clinical experience considered. Exceptionally, candidates may be considered if they have proven excellence in a similar prior position, even if they have less than 3 years international PV experience.

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

Marion Bowden

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