Patient Safety Specialist I

Job Title: Patient Safety Specialist ILocation: Plainsboro, NJ 08536Duration: 6 Months (Possible Extension)Shift: Mon-Fri 8:30 am -5:00 pm (up to 40 hours/week) Plainsboro – ONSITE (the worker can work from home few days/ weeks after discussion with the reporting manager, as needed)ESSENTIAL FUNCTIONSAbility to perform all responsibilities of more junior staff, including but not limited to: Processing of ad-verse events and associated technical complaints and analysis results related to marketed NNI products into the local intake, complaint, and global safety databases, including but not limited to: • Duplicate searches • Product coding • MedDRA coding • Narrative generation • Labeling assessment according to the current approved product label • Receive inbound and make outbound calls for adverse events and technical complaints including handling of refund of replacement requestsQUALIFICATIONS • Bachelor’s degree required (in medical or science-related discipline preferred); relevant experience may be substituted for degree when appropriate (e.g. Registered Nurse with clinical experience). • A minimum of 2 years of progressively responsible, relevant pharmacovigilance experience (including MedDRA coding and adverse event identification) required • A minimum of 2 years of Customer Service experience preferred • Exceptional knowledge of medical and pharmacovigilance terminology required • Knowledge of NNI supported disease states preferred (e.g. diabetes, obesity, hemophilia, growth hormone disorders) • Experience with audits/inspections preferred • Analytical thinking skills required • Proficiency in Windows, Microsoft Word, Excel and Outlook required • Experience with a Call Center and Drug Safety database preferred