Global Safety Officer, I&I

Role Summary

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Location: Morristown, NJ Cambridge, MA. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives.

Responsibilities

• 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

Responsibilities

• 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

Responsibilities

• 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

Responsibilities

• 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

Responsibilities

• 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’ questions
• Support preparation and conduct of Advisory Committee meetings

Responsibilities

• 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.

Qualifications

Knowledge And Skills

• 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 environment
• Excellent teamwork and interpersonal skills are required
• Fluent in English (written and spoken)

Education

• M.D. Degree or equivalent
• For MD, Board Certified/Board eligible, or equivalent, is preferred
• For M.D., minimum 3 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.