Global Safety Officer
Sanofi
4 months ago
Remote friendly (Morristown, NJ)
United States
Medical Affairs
Main Responsibilities
- Provide PV and risk management expertise to internal and external customers
- Act as safety expert for the 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 and represent PV position within project/product teams; partner with external collaborators, key opinion leaders, and Health Authorities during internal/external negotiations
- Provide strategic, proactive safety input into development plans
- Support due diligence activities and pharmacovigilance agreements
Signal Detection & Assessment
- Responsible for signal detection and analysis
- Collaborate with the Center of Excellence for Signal Detection and Data Mining and Safety Epidemiology group
- Identify and implement proactive safety analysis strategies to define the safety profile
- Lead aggregate safety data review 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/plans and monitor effectiveness
- Collaborate with the Center of Excellence for Risk Management and Safety Epidemiology
Submission Activities
- Represent safety position in cross-functional submission teams
- Ensure quality of safety sections in submission documents (generation, consistency, quality)
- Write responses/contributions to health authorities’ questions
- Support preparation and conduct of Advisory Committee meetings
Report Writing
- Document, coordinate, review, and validate periodic safety reports (e.g., RMP updates; IND Annual Report; Annual Safety/Development Safety Update Report; Periodic Safety Update Report)
- Serve as medical safety expert to the GPE Periodic Reports group for assigned projects/products
Qualifications/Education & Work Experience
- M.D. degree or equivalent
- Board Certified/Board eligible (or equivalent) preferred
- Minimum 3 years’ experience in international pharmacovigilance (or equivalent relevant industry experience such as clinical development with clinical experience considered). Exceptionally, candidates may be considered with proven excellence in a similar prior position even with <3 years international PV experience
Skills/Competencies
- Excellent clinical judgment
- Ability to synthesize and critically analyze data from multiple sources
- Ability to communicate complex clinical issues/analysis orally and in writing
- Ability to develop and document sound risk assessments
- Initiative and ability to work under pressure
- Leadership in cross-functional environments
- Excellent teamwork and interpersonal skills
- Fluent in English (written and spoken)
Benefits
- Health and wellbeing benefits, including high-quality healthcare and prevention/wellness programs
- At least 14 weeks’ gender-neutral parental leave
- Provide PV and risk management expertise to internal and external customers
- Act as safety expert for the 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 and represent PV position within project/product teams; partner with external collaborators, key opinion leaders, and Health Authorities during internal/external negotiations
- Provide strategic, proactive safety input into development plans
- Support due diligence activities and pharmacovigilance agreements
Signal Detection & Assessment
- Responsible for signal detection and analysis
- Collaborate with the Center of Excellence for Signal Detection and Data Mining and Safety Epidemiology group
- Identify and implement proactive safety analysis strategies to define the safety profile
- Lead aggregate safety data review 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/plans and monitor effectiveness
- Collaborate with the Center of Excellence for Risk Management and Safety Epidemiology
Submission Activities
- Represent safety position in cross-functional submission teams
- Ensure quality of safety sections in submission documents (generation, consistency, quality)
- Write responses/contributions to health authorities’ questions
- Support preparation and conduct of Advisory Committee meetings
Report Writing
- Document, coordinate, review, and validate periodic safety reports (e.g., RMP updates; IND Annual Report; Annual Safety/Development Safety Update Report; Periodic Safety Update Report)
- Serve as medical safety expert to the GPE Periodic Reports group for assigned projects/products
Qualifications/Education & Work Experience
- M.D. degree or equivalent
- Board Certified/Board eligible (or equivalent) preferred
- Minimum 3 years’ experience in international pharmacovigilance (or equivalent relevant industry experience such as clinical development with clinical experience considered). Exceptionally, candidates may be considered with proven excellence in a similar prior position even with <3 years international PV experience
Skills/Competencies
- Excellent clinical judgment
- Ability to synthesize and critically analyze data from multiple sources
- Ability to communicate complex clinical issues/analysis orally and in writing
- Ability to develop and document sound risk assessments
- Initiative and ability to work under pressure
- Leadership in cross-functional environments
- Excellent teamwork and interpersonal skills
- Fluent in English (written and spoken)
Benefits
- Health and wellbeing benefits, including high-quality healthcare and prevention/wellness programs
- At least 14 weeks’ gender-neutral parental leave