Pharmacovigilance Specialist
Software Specialists - Princeton, NJ

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  • 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
  • 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

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