Global Safety Officer, I&I

*
* Job Title:

** Global Safety Officer, I&I
*
* Location:

** Morristown, NJ Cambridge, MA
** About the Job
***
* 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
* Provide strategic and proactive safety input into development plans
* Support due diligence activities and pharmacovigilance agreements
** Impact:
*** Ongoing assessment of the safety status of the product
* Review, preparation, contribution and/or approval of clinical development documents including clinical development plans, SAPs, study protocols, investigator brochures, data monitoring plans, study reports, integrated summary of safety, summary of clinical safety, and labeling
* Review, preparation, and/or contribution to questions from health authorities, ethics committees, IRBs, external partners
* Management of product safety alerts
* Ensuring the GPE position is well articulated to and understood by its internal and external customers
* Establishment of credibility of GSO function and of GPE
** 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’ 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
* *** Knowledge and Skills
*** 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).
** Formal Education And Experience Required
*** M.D. Degree or equivalent.
* For MD, Board Certified/Board eligible, or equivalent, is preferred
* For M.D., 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.
* 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 it’s 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.

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;

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