Global Safety Officer- Bridgewater/NJ, Cambridge/MA

Job description

Job Summary

Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients.

The Pharmacovigilance, Global Safety (MD) is the safety expert and safety lead for Sanofi products.

Major Duties & 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

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
·  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.

Major Challenges & Problems

·  Providing product safety leadership within project teams having multiple and at times competing priorities and timelines
·  Championing the GPE position within a large and complex organization
·  Determining the appropriate risk minimization and mitigation measures in light of -B/R assessment in coordination with
·  different parties
·  Addressing internal and external customer queries, including those from Health Authorities, in a rapid and effective manner and within appropriate timelines. The above challenges are effectively managed through strong leadership and communication skills paired with an assertive yet collaborative approach, a high level of medical and scientific

Key Internal/External Relationships

·  Internal: other GPE Units, R&D Units and Business Divisions, Scientific Core Platforms, Medical and Regulatory Affairs, Franchise(s), Legal Department, Communication, Affiliates (APH)
·  External: Regulatory/Competent Authorities, Ethics Committee, Investigators, Data Monitoring Committees, partners, CROs

Decision Making Authority

·  Identify potential signals/issues of pharmacovigilance and evaluate product safety
·  Recommend/discuss and coordinate appropriate course of action
·  Ask project/product team for necessary amendments, labelling modifications/variations
·  Lead SMT and SAT
·  Approve safety regulatory and clinical documents including submission, transversal and primary GPE documents as per

SOP Information/Decisions to be referred to hierarchy

·  Transmission of any decision with impact on Study Conduct (e.g. Clinical Hold)
·  Transmission of any safety concerns for which GSO is informed (e.g. Health -Authority restriction/decision)

Basic Qualifications

·  M.D. Degree REQUIRED
·  Minimum 3 years total experience in international pharmacovigilance

Preferred Qualifications

·  Board Certified/Board eligible, or equivalent
·  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
·  Experience in Immunology

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

#GD-SG

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.