Job Details

  • Title: Drug Safety Coordinator
  • Code: RCI-08358/08379
  • Location: Foster City California (CA) 94404
  • Posted Date: 05/19/2020
  • Duration: 6 Months
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  Job Description

Adhere to guidelines that Operations sets on work priorities with input from Manager.

  • Responsible for submission support duties include, but are not limited to, data review, data entry, regulatory submissions of ICSR (Individual Case Safety Report) and aggregate reports to health agencies and third parties
  • Have a basic knowledge of global regulatory reporting requirements
  • Demonstrate consistency and accuracy in output of handling high volume workload and execute stringent deadlines to meet department’s compliance
  • Able to organize and prioritize work load independently utilizing workload resources
  • Should be multi-tasked oriented and be able to take part in department projects which may require cross-training to handle other functions per need basis, in addition to maintaining designated assignments
  • Recognize situations that require escalation and request assistance promptly from senior staff. Remain current with SOPs (Standard Operating Procedures), procedural and training documents, and database technology
  • Ensures compliance with SDEA (Safety Data Exchange Agreement) and other global regulatory reporting requirements for ICSR
Qualifications:
  • Excellent interpersonal communication skills, both written and oral
  • Excellent computer skills in Microsoft environment, Microsoft Excel, PowerPoint and Word. Safety database, familiarity with data retrieval tools, and data entry experience preferred
  • Basic understanding of medical and drug terminology preferred
  • Knowledge and experience with safety reporting and regulatory compliance and experience with international safety reporting/regulations is preferred
  • Must demonstrate initiative, self-motivation, teamwork (collaboration with others), and accountability
  • A quality driven individual with strong attention to detail, accuracy, strong organization skills, and ability to adapt to change and maintain confidentiality is required