Job title: Global Safety Officer, I&I

Location: Cambridge, MA / Morristown, NJ

Main Responsibilities:

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

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 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

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 questions

• 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.

About You

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).

Formal Education And Experience Required:

• 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.

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.

The salary range for this position is:

$178,500.00 - $297,500.00

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the .

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