Safety Officer – Immunology and Inflammation
| Company | Sanofi |
|---|---|
| Location | Cambridge, MA, USA, Bridgewater Township, NJ, USA |
| Salary | $172500 – $249166.66 |
| Type | Full-Time |
| Degrees | MD |
| Experience Level | Mid Level, Senior |
Requirements
- 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)
- M.D. Degree
- For MD, Board Certified/Board eligible, or equivalent, is preferred
- For M.D., minimum 3 years’ and for other degrees, minimum 5 years’ experience in PV
Responsibilities
- 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)
- Communicate with and represent PV analyses and PV position within project/product teams, in safety governance and benefit-risk governance activities and committees (e.g. Safety Management Committee, Benefit-Risk Assessment Committee), 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
- Responsible for signal detection and analysis
- Collaborate with Center of Excellence for Signal Detection, 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
- 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 Epidemiology/Benefit-Risk groups
- 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
- Document, contribute to, coordinate, review and/or 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 GPV Periodic Reports group for assigned projects and products
Preferred Qualifications
- For MD, Board Certified/Board eligible, or equivalent, is preferred