Job Title: Signal Detection/Drug Safety Associate II
Job Location: Bridgewater, NJ
Client –Sanofi (5822901)
Duties:
Please note: The Job Title is Signal Detection and Management Associate
Primary Responsibilities:
The contractor resource will be the key contact on the SM Simplification Project work streams
Bring industry expertise to support the Simplification Project and will provide strategic feedback to GSS and project team.
Assist the Signal Management Lead to develop the new signal detection process and changes to the signal tracking tool.
Assess currently utilized quality documents and develop/modify business processes as needed.
Develop training materials and provide training.
Develop and implement a consistent process to produce KPIs
Work closely with PM to ensure that timelines are met.
Coordinate and lead SMC meetings
Experienced in signal detection tools and processes
Skilled in implementing new business processes and technology solutions for signal detection in clinical development
Experienced in LEAN methodology
Working knowledge of regulations related to signal detection (GVP Module IX).
Proven expertise working with FAERS and WHO-Vigibase data
Ability to review complex information to develop business related strategies for integration of clinical development data and real-world data in the signaling process
At least 5+ years of pharmacovigilance experience, especially in signal detection and management.
Strong consulting experience
Excellent Excel/WP/PowerPoint and technical writing skills
Clinical experience a plus