Work as a Drug Safety Associate in Parexel – B. Pharma/ B. Sc. Nursing/ B. Sc. Life Science can Apply

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Welcome to an exciting opportunity with Parexel, a leading name in the pharmaceutical and healthcare industry. We’re thrilled to announce that we’re expanding our team and are currently seeking a qualified Drug Safety Associate to join us. If you hold a degree in Pharmacy, Nursing, Life Sciences, or any other health-related field, this could be the perfect opportunity for you to advance your career.

Drug Safety Associate

As a Drug Safety Associate at Parexel, you’ll be at the forefront of ensuring the safety and well-being of patients worldwide. Your role will involve critical responsibilities in pharmacovigilance and drug safety, contributing to the development and maintenance of safe and effective pharmaceutical products.

Job Title: Drug Safety Associate

Degree in Pharmacy, Nursing, Life Science or other health-related field, or equivalent qualification/work experience

Knowledge and Experience:
Related experience gained in a healthcare environment is an advantage

Key Accountabilities:
Drug Safety Support:

  1. Assist in development of project specific safety procedures, workflows and template
  2. Assist in project specific safety database setup, development of data entry guidelines, and user acceptance testing
  3. Triage incoming reports for completeness, legibility, and validity
  4. Electronic documentation and quality control of drug safety information
  5. Data entry of case reports into safety database / tracking system
  6. Request follow-up and perform query management
  7. Coding of data in the safety database
  8. Writing case narratives
  9. Create and maintain project specific working files, case report files and project central files
  10. Assist with additional Drug Safety Specialist and/or Safety Service Project Leader (SSPL) activities as required
  11. 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
  12. Support of Medical Directors/Safety Physicians, as needed, in medical monitoring activities
  13. Participate in client and investigator meetings as required
  14. Attend internal, drug safety and project specific training sessions
  15. Perform literature searches
  16. Preparation for, participation in, and follow up on audits and inspections
  17. Delegate work as appropriate to Drug Safety Assistants
  18. Assistance in development of Expedited Reporting Procedures
  19. Assistance with registration with relevant authorities for electronic reporting on behalf of sponsor
  20. 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)
  21. Assist with measuring investigative site performance in conducting required tasks in ISIS Tracking and filing of submission cases as required
  22. Assist with unblinding of SUSARs, as required
  23. Support collection and review of metrics for measuring reporting compliance

1. Analytical and problem-solving skills
2. Able to perform database/literature searches
3. Excellent interpersonal skills
4. Excellent verbal / written communication skills
5. Excellent organizational and prioritization skills
6. Ability to work collaboratively and effectively in a team environment
7. Client focused approach to work
8. Experience with computer applications

Official Website
Job ID R0000020989
Work Location Hyderabad, Telangana, India
Category Medical Sciences
Apply Now Click Here

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