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Associate Safety Director
Vollzeit
ASAP (latest 21.08.2026) - 01.08.2027
We are currently looking for an experienced Associate Safety Director to join a leading global pharmaceutical company in Basel. Start Date: ASAP (Latest 21.08.2026)
Responsible for individual and aggregate case reporting activities including ICSR case management (medical review) and aggregate reporting (i.e. Responsible for signal detection and management activities. Contribute to the strategy and review of safety assessments and drug safety reports for signals or issues (incl, product quality) or in response to Regulatory Authority requests.
Take independent responsibility for risk management activities including preparation and maintenance of CCDS, labeling document maintenance (including IB), risk communications, RMP.
Review of clinical protocols, study reports, Investigator's Brochure (IB), informed consent form (ICF) and other related documents to ensure alignment with the safety strategy and ensure the appropriateness of risk management strategies and risk communication.
Responsible for the preparation and maintenance of safety sections of the Company Core Data Sheet and/or Reference Safety Information in the IB.
Acts independently to manage safety responsibilities on study teams and in activities supporting clinical safety.
May be expected to support non-molecule projects, due diligence evaluations and other projects as needed.
A relevant postgraduate qualification (e.g. PHD/MSc in a Life sciences discipline; PharmD or other post-graduate health professional qualifications) would be advantageous.
~IT/Tool Skills good excel/word/powerpoint skills; Vollzeit
ASAP (latest 21.08.2026) - 01.08.2027
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