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Pharmacovigilance Specialist II
Ref No.: 17-03967
Location: Marlborough, Massachusetts
Start Date / End Date: 05/29/2017 to 05/25/2018
PV Specialist

PV Specialist PLEASE READ ** ONLY submit a candidate who is either a Nurse (RN), Pharmacist (RPh or PharmD) or Physician's Assistant or a person with BS (Life Sciences Background) and minimum of 2 years of pharmacovigilance case processing experience including both clinical trial and post-marketing experience. NOT interested in having an MD The Pharmacovigilance Specialist/Sr. Pharmacovigilance Specialist is responsible for the processing of adverse event information from all sources including clinical trials, post-marketing and published literature. This individual will also be responsible for the preparation of aggregate reports including PSURs, ASRs, DSURs and US Periodic Reports. Additionally, he/she will serve as pharmacovigilance resource to Clinical Development Teams. Specific Responsibilities Include (but are not limited to): • Collect and process incoming adverse event reports from all sources • Perform initial assessment of seriousness, expectedness, causality, and reportability • Complete and QC data entry of incoming reports • Identify missing or discrepant information and perform active follow-up • Prepare expedited reports for submission to regulatory authorities and ethics committees • Serve as pharmacovigilance resource to Clinical Development Teams • Collaborate with clinical development staff on technical and scientific issues regarding SAE and SUSAR reporting • Work closely with safety physicians • • RN, NP or PharmD degree with clinical experience or a person with BS (Life Sciences Background) and minimum of 2 years of pharmacovigilance case processing experience including both clinical trial and post-marketing experience. NOT interested in having an MD • Strong working knowledge of US/EU/AP/LA regulations and ICH guidelines • Working knowledge of MedDRA coding • Understanding of pharmacovigilance -related information systems • Experience with the preparation and submission of regulatory reports • Experience working in electronic document management systems