Pharmacovigilance (PV) Science Manager - CHC
Bridgewater, New Jersey
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Comprehensive coverage including medical, dental, vision, and health and wellness programs.
Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.
At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.
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The Pharmacovigilance (PV) Science Manager is an experienced scientist who provides PV expertise, leadership, mentorship, and supervision to the PV Scientist (PVS) Team in his/her area(s), and assists the Therapeutic Area Head(s) (TAH) in the management of medical, scientific, and administrative responsibilities of their PVS Team including:
- Work prioritization and resource allocation to meet deliverables
- Ensure compliance of relevant activities and quality documents, such as signal detection activities and safety management activities
- Provide coordination and oversight of Implements the strategy for outsourcing activities as applicable (i.e., signal detection reports, analytical reports).
PV Science Manager supports and guides the PVS in the direction and implementing the department’s strategy set by the Global PV Science Head in collaboration with the Safety Team (e.g. the Signal Detection, Risk Management Center of Excellence, and Medical Devices on proactive signal detection and Risk Management activities.)
Outsourcing Initiatives: The nature and scope of The PVS Manager’s vendor oversight include the following activities (specific to Global Business Unit (GBU)):
- The Primary Point of Contact for PVS activities outsourced to service providers for respective GBU;
- Drives and implements the Department’s outsourcing strategies developed for respective GBU by identifying appropriate tasks/products to be outsourced
- Resolves vendor questions, escalates issues according to the governance process
- Represents the PVS Community during the vendor operational governance meetings, providing status updates for respective GBU
- Reviews vendor invoices to ensure accuracy.
Knowledge and Skills
- Working knowledge of global pharmacovigilance practices
- Working knowledge of US and EU pharmacovigilance regulatory requirements
- Think globally and act strategically by knowing the different roles of the corporate support functions and empowering stakeholders to deliver more value to the organization at large
- Experience in leading teams; experience in aligning employees’ competency development plans, and their personal goals and incentives, in line with the company global vision
- Excellent written and verbal communication skills including ability to present scientific data
- Ability to perform personnel management activities with guidance from Global PV Science Lead, including support of recruitment, training, coaching, motivation and performance improvement
- Demonstrated experience in leading teams through critical and non-critical situations
- Proven ability to evaluate, interpret, and synthesize scientific data including clinical and safety data sets
- Team player that thrives in a cross-functional environment
- Self–motivated with the ability to independently prioritize and plan effectively with minimal supervision
- Fluent in English (verbal and written)
- Expertise in coordinating, moderating, and documenting scientific conclusions of cross-functional meetings
- Advanced project management skills with strategic thinking and a keen attention to detail
Formal Education And Experience Required
- Minimum Bachelors of Science in Health Care related field or Health Care Professional (Life Sciences degree, RN, BSN, Nurse Practitioner, Physician Assistant or RPh); or preferred advanced health care discipline degree (PharmD, PhD, Master of Science, etc.); or equivalent qualification with at least 5 years industry experience and required analytical skills.
- Preferred at least 5 years industry experience with a working knowledge of drug safety and risk management, drug development, basic knowledge of regulatory guidelines and medical coding (i.e., MedDRA)
- Basic knowledge of common data processing software (i.e., Excel, PowerPoint, Word) and database systems
- Intermediate experience in aggregate data analysis
- Previous experience in managing small teams preferred.
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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