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.

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

Education:
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

Skills:
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

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