Global Safety Officer, Rare Diseases

Role Summary

Global Safety Officer, Rare Diseases. Location: Morristown, NJ; Cambridge, MA. Responsible for internal and external safety leadership, sponsor risk management, and cross-functional safety activities in pharmacovigilance within a rare disease portfolio.

Responsibilities

• Provide PV and risk management expertise to internal and external customers
• Act as safety expert for product with continuous learning mindset; understand product attributes and science
• Maintain knowledge of product, environment, and recent literature
• Maintain expertise in drug safety and PV; understand international safety regulations and guidelines
• Lead cross-functional Safety Management Teams (SMTs) and GPV internal Safety Analysis Teams (SATs)
• Communicate and represent PV position within project/product teams, with external partners, key opinion leaders, and Health Authorities; participate in internal and external negotiations
• Provide strategic and proactive safety input into development plans
• Support due diligence activities and pharmacovigilance agreements

Impact

• 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/requests from health authorities, ethics committees/IRBs, external partners
• Management of product safety alerts
• Ensuring the GPV‚Äôs position is well articulated to and understood by internal and external stakeholders
• Establishment of the credibility of the GSO role/function and GPV
• Signal Detection and Assessment: oversee signal detection and analysis from multiple contributors; collaborate with Center of Excellence for Signal Detection and Data Mining and Safety Epidemiology group
• Identify and implement proactive safety analysis strategies to define safety and Benefit Risk profile
• Lead the review of aggregate safety data and coordinate safety surveillance activities

Qualifications

Knowledge and Skills

• Excellent clinical judgment
• Articulate and clear in telephone communications
• Ability to synthesize and critically analyze data from multiple sources with sound clinical reasoning
• Ability to communicate complex clinical issues orally and in writing
• Ability to develop and document sound risk assessments
• Initiative, ability to work under pressure, and prioritization of business-critical deliverables
• Leadership within cross-functional teams
• Excellent teamwork and interpersonal skills
• Fluency in English (written and spoken)

Education

• D.O., M.D. or equivalent
• Board Certified/Board eligible or equivalent preferred
• Minimum 3 years total experience in international pharmacovigilance or equivalent relevant industry experience; exceptional candidates with less PV experience but proven excellence may be considered