Pharmacovigilance Therapeutic Area Strategy Lead (Senior DIrector)
Bridgewater, NJ;Lyon;Toronto, ON;Swiftwater, PA
Sanofi, in the U.S. and Canada, strives to create a diverse and inclusive work environment that empowers employees to drive their careers and be successful. The talent we look for will contribute to the organization in innovative, insightful, and creative ways in order to strengthen our dynamic culture and drive us collectively to make a difference in the lives of patients.
HEALTH AND WELLNESS PROGRAMS
Comprehensive coverage including medical, dental, vision, and health and wellness programs.
Employer matching because Sanofi invests in their employees!
Sanofi is eager to further your development and expertise in an ever challenging environment.
Sanofi understands the importance of family. We offer a variety of support including maternity/paternity leave.
PAID TIME OFF
Enjoy 3 weeks’ vacation and paid holidays, including company shutdown at the end of every year!
Importance of life outside of the office is valued at Sanofi.
The TA Strategy Lead provides PV expertise, leadership, and mentorship of relevant Therapeutic Area members and GPV personnel assigned to the respective organization or product to ensure appropriate assessment of Safety information related to all Sanofi products through the management of all medical, scientific and administrative responsibilities. The TA Strategy Lead deputizes for and assists the TA Head, and he or she is the key accountable contact to internal and external stakeholders for specific PV activities, e.g. Structured Benefit-Risk Assessments.
JOB DUTIES AND RESPONSIBILITIES:
Deputize for the TA Head:
- In times of absence or unavailability
- Matrix Leadership of Global Safety Officers (GSO)
- Maintain Therapeutic Area expertise, product portfolio-specific expertise and ongoing assessment of therapeutic areas, competitive drugs and therapies and applicable regulations
- Assist TA Head to develop and support processes that ensure state-of-the-art PV contributions
- Assist TA Head in preparing for Advisory Committees / Oral Explanations / Major regulatory meetings
- Foster communication and collaboration with other TA Strategy Leads to standardize best practices
- Foster communication and collaboration with other TA Strategy Leads on GSO challenges with regard to daily activities
- To prepare for ebbs and flow of GSO activities and resource needs
- Design plan to drive alignment of stakeholder thinking on benefits, risks, uncertainties
- Champion the implementation of structured benefit-risk assessment
- Partners with TA Head to determine extent and appropriate methodology for structured benefit-risk assessment
- Project planning for structured benefit-risk assessment, including for which products (calendar of preparation, assessment timing, and milestones)
- Liaise with GSS Safety Analyses Innovation and Submission Readiness Lead for GBU/TA specific:
- Submission readiness activities
- Drive performance of analyses important for the submission
- Ensuring execution of the overall safety strategy in alignment with Key Messages
- Ensuring that key messages are robustly supported by data; when not supported by data, that key messages are challenged appropriately
- Safety and benefit-risk consultant readiness
- Biostatistics and Epidemiology coordination and liaison o Liaison to Epi & B-R team for execution of TA-specific B-R strategy
- Interact with clinical development, regulatory, preclinical, labeling, clinical operations, medical writing, legal, medical affairs, and review and governance committees, as well as external Company partners, and regulatory authorities
Training & Mentorship:
- Mentor and develop GSO competencies for structured benefit-risk assessment, and other staff in the functional therapeutic area
- Patient preferences o Semi-quantitative and fully quantitative methodologies for benefit-risk assessment
- Liaison to Epidemiology & Benefit-Risk team to train and promote design of TA-specific benefit-risk assessment strategy
Internal development and benefit-risk committee preparations:
- BRAC preparations o Coordinator for GPV Pre-BRAC meetings
- Drive GPV team preparations for Pre-BRAC meetings
- Ensure appropriate cross-functional input for Pre-BRAC meetings
- DWG preparations
- Support GSS Head in DWG preparations by ensuring intra-GPV sharing of information and alignment of GPV position
REQUIRED EDUCATIONAL BACKGROUND AND JOB-RELATED EXPERIENCE:
- Required: Good working knowledge of risk management and signal detection
- Advanced understanding of structured benefit-risk assessment
- Advanced understanding of Quantitative Patient Preferences
- Advanced understanding of Adaptive Pathways
- Experience Chairing executive decision-making bodies
- Experience with integration of new acquisitions/products
- Hands on experience designing, planning and implanting an effective formal crisis prevention program
- Excellent knowledge of PV and medical safety
- Experience in interactions with key regulatory agencies
- Proven ability to motivate, problem-solve, prioritize, take initiative, and meet challenges in a matrix setting
- Proven ability to influence others in a matrix setting
- Excellent clinical judgment
- Capability to synthesize and critically analyze data from multiple sources
- Ability to communicate complex clinical issues and analysis verbally and in writing
- Able to develop and document sound risk assessment
- Able to guide a team in developing a sound benefits assessment
- Demonstrates initiative and capacity to work under pressure
- Demonstrated readiness, or readiness within 1 year, to move from an individual contributor role to a managerial role in a scientific function
- Demonstrates leadership within cross-functional team environment
- Excellent teamwork and interpersonal skills
- Fluent in English (written and spoken)
- Preferred M.D. Degree, Board Certified on Board Eligible or equivalent in relevant clinical specialty
- 5-10 years total experience in PV and/or relevant medical field or equivalent, including a preferred minimum 5 years of international pharmaceutical activities (such as Research & Development, Medical affairs)
- Minimum 3 years supervisory/ management experience or equivalent in matrix organization with proven proficiency in organizational and planning capabilities is desired
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.
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.
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