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Apply Online for Drug Safety Associate Position @ Paraxel

In a PAREXEL Pharmacovigilance job, you’ll deliver patient safety services to help bio/pharmaceutical companies meet increasing safety obligations. You will support operational requirement changes, help lower safety monitoring costs, and ensure the team meets all regulatory requirements and post-authorization commitments. Help deliver the next generation of Pharmacovigilance services with a leader in product safety services and solutions

Job Title : Drug Safety Associate

Job ID : 38083BR

Job Description:

  • Assist in development of project specific safety procedures, workflows and templates
  • Assist in project specific safety database setup, development of data entry guidelines, and user acceptance testing
  • Triage incoming reports for completeness, legibility and validity
  • Electronic documentation and quality control of drug safety information
  • Data entry of case reports into safety database / tracking system
  • Request follow-up and perform query management
  • Coding of data in the safety database
  • Writing case narratives
  • Create and maintain project specific working files, case report files and project central files
  • Assist with additional Drug Safety Specialist and/or Medical Operations Leader (MOL) activities as required
  • Inform Line Manager (LM)/Team Manager, Medical Operations Leader (MOL) or Project Leader (PL) and
  • Regional Head of PV Operations of potential change-in-scope of projects
  • Support of Medical Directors/Safety Physicians, as needed, in medical monitoring activities
  • Participate in client and investigator meetings as required
  • Attend internal, drug safety and project specific training sessions
  • Perform literature searches
  • Preparation for, participation in, and follow up on audits and inspections
  • Delegate work as appropriate to Drug Safety Assistants
  • Assistance in development of Expedited Reporting Procedures
  • Assistance with registration with relevant authorities for electronic reporting on behalf of sponsor
  • Assistance with setting up and deployment of worldwide reporting as required to regulatory authorities, CECs, local ECs, and investigator sites (electronic and hard copy)
  • Submission of safety reports to investigators via ISIS (International Safety Information System)
  • Assist with measuring investigative site performance in conducting required tasks in ISIS
  • Tracking and filing of submission cases as required
  • Assist with unblinding of SUSARs, as required
  • Support collection and review of metrics for measuring reporting compliance
  • Support Global Pharmacovigilance Information Office (GPIO) in the collection and organization of global PV requirements
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  • Degree in Pharmacy, Nursing, Life Science or other health-related field, or equivalent qualification/work experience
  • Associates degree in any of the above with appropriate work experience

Click here to Apply Online

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