Sanofi Group PV Scientist in Bridgewater, New Jersey
The Pharmacovigilance Scientist (PVS) is a Safety Expert who is responsible for performing core pharmacovigilance activities on a product, or group of products in a therapeutic area or franchise, in partnership with the Global Safety Officer (GSO) to identify signals and evaluate safety data for both marketed products and products in clinical development. This includes performing proactive signal detection and safety management committee activities, authoring safety evaluations, defining scope and methodology, in agreement with the GSO, for aggregate safety reports, conducting preliminary safety analysis, preparing ad hoc Health Authority responses, driving the end-to-end signal management process for assigned products (i.e., signal tracking, data analysis, leading review meetings, presenting, etc.) in collaboration with the GSO and Pharmacoepidemiology. The PVS also partners with the Safety Team to manage other safety related activities associated with new drug applications / regulatory filings, benefit risk assessment and safety risk management and support activities related to risk minimization including dRMP/RMPs. The PVS manages the coordination and oversight to outsourced activities (i.e., signal detection reports, safety evaluation reports).
The nature and scope of PVS vendor oversight include the following activities specific to Global Business Unit (GBU):
• Determines tasks to be outsourced on a unit;
• Oversees tasks outsourced to service providers for respective GBU;
• Provides clear direction to vendor for expected deliverables and timelines for completion;
• Provides background information and necessary interval and cumulative data for safety analysis(es) including (but not limited to) most current company core labeling and PBRER, signal source, and safety database and literature outputs;
• Resolves vendor questions and escalates issues to in-house PV Science Manager as appropriate
• Provides regular vendor feedback to in-house PV Science Manager for inclusion into the Vendor Operational Governance Meetings;
• Reviews and approves vendor invoices related to outsourced PVS tasks to ensure accuracy of unit charges for respective GBU.
Knowledge And Skills:
• Strong knowledge of pharmacovigilance practices
• Working knowledge of US and EU pharmacovigilance regulatory requirements
• Excellent written and verbal communication skills in English
• Ability to present and critically discuss safety data in both internal and external discussions
• Ability to evaluate, interpret and synthesize scientific data (analytical thinking)
• Team player that performs effectively in a cross-functional environment
• Self–motivated, able to prioritize and plan effectively and independently, with minimal supervision
• Ability to coordinate, moderate, and clearly document conclusions of cross-functional scientific meetings
• Ability to navigate in databases and pull information correctly
• Advanced project management skills with a keen attention to detail
B. Key Functional Competencies :
Signal Detection: Safety Surveillance & Data Gathering
Expertise in the collection of drug safety information from a variety of sources throughout the product life cycle to proactively detect and validate potential signals. Continuously evaluates and adopts the most suitable tools to optimize the collection of safety information and detection of signals.
Signal Assessment & Risk Classification
Ability to evaluate safety signals to determine causality and risk classification while accounting for potential confounding factors
Education And Experience Required:
Minimum Bachelors of Science or Health Care Professional (RN, BSN, Nurse Practitioner or Physician Assistant, RPh); or preferred advanced health care discipline degree (PharmD, PhD, Masters of Science, etc.) or equivalent qualification.
• Preferred 2 years with relevant experience (including industry experience) with a working knowledge of drug safety and risk management, and understanding of drug development, basic knowledge of regulatory guidelines and medical coding (i.e. MedDRA).
• Working knowledge of common data processing software (i.e., Excel, PowerPoint, Word) and database systems
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.