Job Description R&D Partners is seeking to hire a Pharmacovigilance Scientist in Cambridge, MA. Your main responsibilities as a Pharmacovigilance Scientist : Works closely with the safety physician to analyze potential safety issues, including signal detection, signal evaluation and signal management Contribute to signaling and data mining activities utilizing internal and external sources of data Performs signaling data review from all sources including but not limited to: Empirica, Clinical and Safety outputs, Literature, and HA requests Assist in the evaluation of potential safety issues and quality risk assessment reports utilizing all processes and templates Together with safety physician manages leads the authoring for aggregate safety reports (e.g. PSUR, DSUR, Line listings) in close collaboration with the cross functional lead and operational functions Supports all SRMT preparation and documentation with guidance from mentor and safety physician Working with affiliate management and regulatory to develop and edit SMPs/ESRPs and independently bringing issues related to SMPs and ESRPs for discussion with impacted parties Contribute to activities related to the functioning of safety committees, including but not limited to, preparing reports, minutes, and meeting documents; ensuring completion of action items; and participating in the discussion of patient safety issues What we are looking for in a Pharmacovigilance Scientist : Degree in a medical or healthcare related discipline (MSN RN, PharmD, Physician Assistant, MD) is required A minimum of three to five years in the pharmaceutical industry with experience in drug safety/pharmacovigilance ARGUS and Empirica PSUR, DSUR for Aggerate reporting Must have clinical background Authoring experienceVery analytic Why Choose R&D Partners ? As an employee, you have access to a comprehensive benefits package including: Medical insurance PPO, HMO & HSA Dental & Vision insurance 401k plan Employee Assistance Program Long‑term disability Weekly payroll Expense reimbursement Online timecard approval Salary: $74.98 to $81.50 (Dependent on Experience) R&D Partners is an equal‑opportunity employer. #J-18808-Ljbffr R&D Partners
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