Global Safety Officer
BioSpace · Cambridge, MA · 4 wk ago
On-siteManagementFull-time
About The Job
Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, you'll drive breakthroughs that could turn the impossible into possible for millions.
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
- Support due diligence activities and pharmacovigilance agreements
- Signal Detection & Assessment
- 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
- Proactively assess risks and develop risk management strategies and plans
- 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
- Qualifications/Education & Work Experience:
- M.D. Degree or equivalent
- For MD, Board Certified/Board eligible, or equivalent, is preferred
- 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
Competencies
- Excellent clinical judgment
- Capability to synthesize and critically analyse data from multiple sources
- Able to communicate complex clinical issues and analysis orally and in writing
- 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)
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