Le contenu de ce poste est libellé en anglais car il nécessite de nombreuses interactions à l'international, l'anglais étant la langue de travail.

About the opportunity

Sanofi Genzyme is looking for a Global Safety Officer in the field of Oncology.

In this role, you provide medical input on the safety evaluation of established drugs and drugs under development. This will contribute to innovative new therapies in Oncology which will directly improve the life of patients.

About Sanofi Genzyme

Sanofi Genzyme is the specialty care global business unit of Sanofi, focused on rare diseases, multiple sclerosis, oncology, immunology and rare blood disorders. We help people with debilitating and complex conditions that are often difficult to diagnose and treat. We are dedicated to discovering and advancing new therapies, providing hope to patients and their families around the world.

Our ambition is to be the industry leader in specialty care. We currently provide more than 20 treatments to patients globally, with many potential new therapies being studied in clinical trials and in Sanofi laboratories.

RESPONSABILITIES

In this role you will be active in five main areas

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
• Impact

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

PROFILE

Qualifications/Education & Work experience

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

Inspire your Journey, what Sanofi can offer you

• An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team
• You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully
• As a globally successful and constantly growing company, Sanofi provides international career paths as well

This is our Sanofi, Discover yours.

Please provide your resume in PDF format and a motivation letter

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.