Pharmacovigilance Scientist

Experience Required2 years experience in job offeredMinimum Education RequiredMaster degree in Chemistry, Pharmaceutical Science, or PharmaceuticsLicense(s) Required0Training Required/Provided0Compensation$130,000.00 - $133,000.00 / YearlyHours Per Week40Number Of Positions1ShiftFirst Shift (Day)Job DescriptionPharmacovigilance Scientist (Piscataway, NJ) – Study and analyze active drug ingredient and chemical reaction issues across the drug development life cycle using synopsis, ICFs, SAPs and CRFs; Involve in escalation processes, risk evaluation, and analysis of safety data in compliance of FDA CFR, ICH, and EU GVP using RMP (Risk Management plans) and REMS (Risk Evaluation and Mitigation Strategy); Analyze and reconcile safety data of drugs within a clinical program between Global Patient Safety and Post Marketing programs using Strategic Safety Advisory to Clinical Development; Identify potential drug issues and escalate to the medical review function, applying PV System & Data Integrity, and Medical ICSR Review; Contribute to safety sections of the investigational new drug and new drug applications, investigator or regulator communications, Investigator brochure, and other reports (DSUR); Perform Quality Review of the Individual Case Safety Report, including data and a concise, medically relevant narrative. Must have a Master degree in Chemistry, Pharmaceutical Science, or Pharmaceutics plus 2 years experience in job offered. Require skills and working knowledge of Strategic Safety Advisory to Clinical Development, PV System & Data Integrity, Medical ICSR Review, RMP, REMS, Global Patient Safety program. Allow telecommuting. Standard benefits with $130k~$133k/year. Submit résumé referencing job code VEK007 to HR, Abla Life Sciences, 15 Corporate Place South, Suite 341A, Piscataway, NJ 08854.Place of WorkOn-siteRequisition IDVEK007Job TypeFull TimeApplication InstructionsSubmit résumé referencing job code VEK007 to HR, Abla Life Sciences, 15 Corporate Place South, Suite 341A, Piscataway, NJ 08854.