Assist in development of project specific safety procedures, workflows and templates
Assist in project specific safety database setup and user acceptance testing
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
Assist with additional Drug Safety Specialist and/or Medical Operations Leader (MOL) activities as required
Inform Line Manager (LM)/Team Manager, Medical Operations Leader (MOL) or Project Leader (PL) and Regional Head of PV Operations of potential change-in-scope of projects
Participate in client and investigator meetings as required
Attend internal, drug safety and project specific training sessions
Preparation for, participation in, and follow up on audits and inspections

Qualifications

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

Education:

• Degree in Pharmacy, Nursing, Life Science or other health-related field, or equivalent qualification/work experience
• Associates degree in any of the above with appropriate work experience