Parexel is Hiring Drug Safety Associate I - For Freshers - Apply Before 14th June 2024

Responsibilities :

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)
21.     Submission of safety reports to investigators via ISIS (International Safety Information System)
22.     Assist with measuring investigative site performance in conducting required tasks in ISIS
23.     Tracking and filing of submission cases as required
24.     Assist with unblinding of SUSARs, as required
25.     Support collection and review of metrics for measuring reporting compliance

Requirements :

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

Location - Chandigarh/Mohali

Note: Shortlisted candidates will be invited for a face-to-face interview in the respective location.

No work from home request will be accepted.

Assignment Category - 1 Year Contract

Last date to apply - 14 June 2024