Associate Safety Director
(m/f/d)
Freelance/temporary employment for a project Basel Stadt Start date: asap Reference number: 843422/1
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Responsibilities
1. Lead safety oversight for assigned products, including signal detection, risk management, and regulatory submissions
2. Manage individual and aggregate case reporting (ICSR, DSUR, PBRER) and contribute to safety assessments
3. Maintain and update safety documentation (CCDS, IB, RMP, ICF) and ensure alignment with safety strategy
4. Represent safety science in regulatory filings and internal governance committees
5. Collaborate with global teams and vendors to ensure compliance with GxP and clinical trial lifecycle standards
Profile
6. Qualified healthcare professional or Life Sciences graduate (PhD/MSc/PharmD preferred)
7. Solid amount of drug development experience, including experience in drug safety/pharmacovigilance
8. Strong skills in data analysis, safety database tools, and Microsoft Office suite
9. Fluent in English (written and verbal) with excellent communication and presentation abilities
10. Proven ability to work independently and manage complex safety responsibilities across global teams
Benefits
11. Remote-option
12. Strategic leadership role with direct impact on global safety and regulatory outcomes