Safety Database Specialist / Clinical Trial Drug Safety Associate I
Everest Clinical Research · Sofia
Описание на позицията
About the role
Everest is seeking a Safety Database Specialist / Clinical Trial Drug Safety Associate I to support Argus Safety database operations for clinical trials. The role is based in Sofia, Bulgaria and involves both database development and administration to meet drug safety objectives.
Key responsibilities
- Support day‑to‑day operation of Argus Safety, focusing on database development and administration.
- Configure Argus Safety for new clients, products, and studies across development, validation, and production environments.
- Manage user privileges and workflow settings, and perform post‑go‑live database modifications.
- Maintain and update technical specifications documentation (Configuration Specifications Document) for each change control.
- Develop UAT scripts for new builds or modifications and lead UAT validation activities.
- Review protocols and reference materials to contribute to project timelines and ensure good project management practices.
- Assist Pharmacovigilance and Drug Safety teams in planning, directing, and managing safety database development and maintenance.
Required profile
- Committed, skilled, and customer‑focused individual.
- Ability to work collaboratively with safety and pharmacovigilance teams.
- Strong attention to detail and documentation accuracy.
Required skills
- Argus Safety
- Database configuration and administration
- UAT script development
- Technical specifications documentation
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Everest Clinical Research
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