Drug Safety Specialist at Parexel

Remote
Parexel

Title: Drug Safety Specialist

  • Location: USA – Any Region – Home Based

Job Description:

The Drug Safety Specialist will provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).

  • 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 Safety Services Project Leader (SSPL)activities as required
  • Inform Line Manager (LM)/Team Manager, Safety Services Project Leader (SSPL) 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

Qualifications:

Skills:

  • Analytical and problem-solving skills
  • Able to perform database/literature searches
  • Excellent interpersonal skills
  • Excellent verbal / written communication skills
  • Excellent organizational and prioritization skills
  • Ability to work collaboratively and effectively in a team environment
  • Client focused approach to work
  • Experience with computer applications

Knowledge and Experience:

  • Related experience gained in a healthcare environment is an advantage

Education:

  • 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

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