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.
- 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:
- Minimum 2 years experience in ICSR Case processing.
