Parexel Drug Safety Associate Role For Pharma – Apply Online
Drug Safety Associate II
SAS Nagar (Mohali), India
Job ID: R0000026858
Category: Medical Sciences
About this Role
The Drug Safety Associate II will provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).
Key Accountabilities:
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
- Perform electronic documentation and quality control of drug safety information
- Data entry of case reports into the safety database/tracking system
- Request follow-up and perform query management
- Code data in the safety database
- Write 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 changes in the scope of projects
- Support 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
- Prepare for, participate in, and follow up on audits and inspections
- Delegate work as appropriate to Drug Safety Assistants
- Assist in the development of Expedited Reporting Procedures
- Assist with registration with relevant authorities for electronic reporting on behalf of the sponsor
- Assist with setting up and deployment of worldwide reporting as required to regulatory authorities, CECs, local ECs, and investigator sites (electronic and hard copy)
- Submit safety reports to investigators via ISIS (International Safety Information System)
- Assist with measuring investigative site performance in conducting required tasks in ISIS
- Track and file 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
- Ability to perform database/literature searches
- Excellent interpersonal skills
- Strong 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:
- Two years of relevant experience in ICSR case processing.
Education:
- Degree in Pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification/work experience
- Associate’s degree in any of the above with appropriate work experience
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