- Attend internal, drug safety and project specific training sessions.
- 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.
- Participate in client and investigator meetings as required.
- 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.
- Degree in Pharmacy, Nursing, Life Science or other health-related field, or equivalent qualification/work experience.
- Degree in any of the above with appropriate work experience.
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