Drug Safety Associate I

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:

• Related experience gained in a healthcare environment is an advantage

Edu/cation:

• M.Pharm/Pharm D/BDS/Msc (PV/Clinical Research)