Parexel Life Sciences Job
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Parexel Life Sciences Job – Drug Safety Associate Vacancy

MSc & BSc Life Sciences candidates are requested to apply for a Drug Safety Associate position at Parexel. Parexel is hiring biosciences for a Drug Safety Associate position. Parexel Drug Safety Associate careers. Parexel has Drug Safety Associate job openings for msc life sciences candidates. Check out all of the details on the same below:

Designation: Drug Safety Associate

Requisition ID: 53171BR

Location: Hyderabad, Telangana, India

Job Description:

  • Help in the development of project specific safety Processes, 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 keep project-specific working files, case report files and project central files
  • Help with added Drug Safety Specialist on tasks as needed
  • Inform Line Manager (LM)/Team Manager, Safety Services Project Leader (SSPL) or
  • Project Leader (PL) and Regional Head of PV Operations of possible change-in-scope of endeavours
  • Support of Medical Directors/Safety Physicians, as required, in medical monitoring actions
  • Participate in client and investigator meetings as needed
  • Attend internal, drug safety and project specific training sessions
  • Perform literature searches
  • Preparation for, participation in, and also follow up on evaluations and audits
  • Delegate work as appropriate to Drug Safety Assistants
  • Assistance in development of Expedited Reporting Procedures
  • Assist with registration with relevant authorities for electronic reporting on behalf of the sponsor
  • Assist with setup and deployment of worldwide reporting as necessary to regulatory authorities, CECs, local ECs, and investigator websites (electronic and hard copy)
  • Submission of safety reports to investigators through ISIS (International Safety Information System)
  • Assist with measuring investigative site performance in conducting necessary tasks in ISIS
  • Tracking and filing of submission cases as needed
    help with unblinding of SUSARs, as necessary
  • 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
See Also
Govt NCCS BSc & MSc Life Sciences Research Personnel Recruitment 2019

Qualifications:

  • Degree in Pharmacy, Nursing, Life Science or other health-related fields, or equal qualification/work experience
  • Associates degree in some of the aforementioned with appropriate work experience of 1-2 years in Pharmacovigilance.

Apply Online

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