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 YouKnowledge 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 it's 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 LINK.
#GD-SA
#LI-SA
#LI-Onsite
#vhd
