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About Company

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Position Name :

Drug Safety Associate-II

Organization :

Parexel

Qualification:

B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences, Nursing

Experience:

1 to 2 Years

Salary:

25,000 - 35,000 /month

Location:

Mohali

Drug Safety Support:

  • Assist in the 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 Service 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.

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:

  • Minimum 2 years experience in ICSR Case processing.

Application Link