Pharmacovigilance Safety Coordinator

6/20/2019

POSITION SUMMARY: The Safety Coordinator assists in the processing of Serious Adverse Events (SAE) and Adverse Drug Reactions (ADR) in Clinical Trials and performs individual case safety reports (ICSR) processing in the Post-marketing settings.

THIS IS AN ENTRY-LEVEL POSITION


RESPONSIBILITIES:

  • Enter incoming safety events into related tracking systems and databases
  • Handle incoming safety-related reports from clinical trial sites
  • Process expedited/non-expedited safety events based on Safety Data Analyst’s evaluation in accordance with company’s SOPs and other regulatory guidelines
  • Write SAE narratives
  • Perform data reconciliation for ad hoc and annual safety reports
  • Organize, attend and take minutes of Safety Department meetings
  • Provide administrative/logistical support for the Safety Department
  • Other duties, as assigned e.g. assist with medical coding activities

REQUIRED EDUCATION AND EXPERIENCE:

  • RN, Bachelor’s degree in scientific or medical curriculum, or equivalent professional experience
  • Competent in the use of Microsoft Office software
  • Understanding of medical terminology
  • Ability to work effectively both independently and in a team environment
  • Strong problem solving and decision making skills
  • Strong verbal and written communication skills
  • Written communication abilities to include drafting of memos, formatting and taking minutes
Job Type : Full-Time
Education Level : Bachelors Degree
Experience Level : ""
Job Function : ""
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