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Drug Safety Life Science Job – Apply Online @ Parexel

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

Designation: Drug Safety Associate

Requisition ID: 56022BR

Location: Hyderabad, Telangana, India

Job Description:

  • Assist in the development of project-specific safety procedures, workflows as well as templates
  • Help in project-specific safety database setup, development of data entry standards, as well as user acceptance testing
  • Triage incoming reports for completeness, legibility and also the validity.
  • Electronic documentation as well as quality control of drug safety info
  • Data entry of case reports into safety database/ tracking system
  • Request follow-up as well as perform query management
  • Coding of data in the safety database
  • Writing case narratives
  • Create and also maintain project-specific working files, case report files and also project central files
  • Aid with extra Drug Safety Specialist on activities as needed
  • Inform Line Manager (LM)/ Team Manager, Safety Services Project Leader (SSPL) or
  • Project Leader (PL) and also Regional Head of PV Operations of potential change-in-scope of projects
  • Support of Medical Directors/Safety Physicians, as required, in medical monitoring activities
  • Participate in the client as well as investigator meetings as needed
  • Participate in internal, drug safety as well as project-specific training sessions
  • Perform literary works searches
  • Preparation for, participation in, and also 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 appropriate authorities for electronic reporting on behalf of the sponsor
  • Assistance with establishing and deployment of around the world reporting as required to regulatory authorities, CECs, local ECs, as well as investigator sites (electronic and hard copy).
  • Submission of safety reports to investigators via ISIS (International Safety Information System).
  • Aid with measuring investigative site performance in conducting required tasks in ISIS.
  • Tracking and also filing of submission cases as required.
  • Help with unblinding of SUSARs, as required.
  • Support collection and also the review of metrics for measuring reporting compliance.
  • Support Global Pharmacovigilance Information Office (GPIO) in the collection and organization of global PV requirements.
See Also
PPD Life Sciences Monitor Job - BSc Candidates Apply Online

Qualifications:

  • Degree in Pharmacy, Nursing, Life Science or other health-related fields, or equal qualification/work experience.
  • Associates degree in any of the above with appropriate work experience.

See Also: Drug Safety Associate – Pharmacovigilance As A Career

Apply Online

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