Drug Safety Associate II
Job ID R0000031576 Category Medical SciencesAbout this Role
Job Purpose:
- 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).
- Responsible for processing of Individual Case Safety Reports (ICSRs) from various sources, Literature search and review, signal detection and management, tracking regulatory information, performing regulatory submissions and supporting preparation of aggregate and other study reports, as well as Medical and Product Dictionary Management activities, where applicable
- Responsible for ICSR compliance and related processes including but not limited to quality review of ICSRs, metrics generation and late case investigation in accordance with International and local regulatory reporting requirements, where applicable
Key Accountabilities:
Drug Safety Support:
- Assist in development of project specific safety procedures, workflows and template
- 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:
- 2 Years related experience gained in Pharmacovigilance.
Education:
- Degree in Pharmacy, Nursing, Life Science or other health-related field, or equivalent qualification/work experience
- A degree in Medicine/Dentistry/physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage.
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