Pharmacovigilance Specialist
Software Specialists - Princeton, NJ

This job posting is no longer available on JobServe USA. Find similar jobs: Pharmacovigilance Specialist jobs - Software Specialists jobs

Description:
  • The Pharmacoviglance 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
  • Coordinate and prepare aggregate reports
  • Serve as aggregate report owner with overall responsibility for completeness and consistency in conjunction with PV Physician
Qualifications:
  • RN, NP or PharmD degree with clinical experience _MUST HAVE THIS EXPERIENCE
  • Minimum of 2 years of pharmaceutical/biotechnology industry experience in PV including both clinical trial and post-marketing experience
  • 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

JobServe USA - 30+ days ago - save job - block
Recommended Jobs
Medical Information Specialist (TS-3)
Clinical Solutions Group - Plainsboro, NJ
Clinical Solutions Group - 4 days ago

Senior Regulatory Compliance Specialist
HLM Clinicals - Bridgewater, NJ
Monster - 16 days ago

Senior Specialist, Epidemiology
Experis - Bridgewater, NJ
Experis - 25 days ago