Associate Safety Director

We are seeking an experienced and highly motivated Associate Safety Director to join a global pharmaceutical development environment within a Portfolio Safety Science team. The role provides end-to-end safety science and pharmacovigilance support across early and late-phase development programs as well as marketed products. The successful candidate will play a key role in ensuring patient safety by leading and contributing to all aspects of product safety strategy, risk management, and regulatory compliance.

The position requires a strong background in drug development and pharmacovigilance, with the ability to work independently and apply expert judgment in complex safety evaluations. The Associate Safety Director will collaborate closely with cross-functional global teams and safety leadership, contributing to both strategic and operational safety deliverables. The role includes responsibility for signal detection and evaluation, aggregate safety reporting, regulatory submissions, and the maintenance of core safety documents. Strong communication, analytical skills, and the ability to present complex safety data clearly are essential.

This is a 12-month contract position based in Basel , offering a full-time workload. During the first three months, full on-site presence is expected for training purposes, followed by a hybrid working model. The latest possible start date is 21 August 2026 .

Tasks & Responsibilities:

• Develop and maintain an understanding of the safety profile of their assigned product(s) or therapy areas. Develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as understanding of the relevant strategic context (e.g., disease under study, safety profile of competitors, mechanism of action).
• Responsible for individual and aggregate case reporting activities including ICSR case management (medical review) and aggregate reporting (i.e. DSUR, PBRER).
• 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.
• Provide expert contribution to the development of the product safety strategy.
• 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.
• Take responsibility for safety science contributions to regulatory authority submissions (Investigational New Drug/IND applications, New Drug Applications/NDAs, Marketing Authorization Applications/MAAs, Variations, Renewals, etc.).
• Responsible for the preparation and maintenance of safety sections of the Company Core Data Sheet and/or Reference Safety Information in the IB.
• Participate in and provide input for Drug Monitoring Committees (iDMC) or internal monitoring committee (IMC) meetings, as applicable.
• In partnership with the SSL, support presentation of important safety issues to the Drug Safety Committee (DSC), Development Review. Committee (DRC) and other internal and external review and governance committees as needed.
• Acts independently to manage safety responsibilities on study teams and in activities supporting clinical safety.
• Take on the responsibility for specialised roles with PCS. These may include, but are not limited to; functional business process owner, subject matter expert.
• May be expected to support non-molecule projects, due diligence evaluations and other projects as needed.
• Perform specialized roles with PCS. These may include, but are not limit