Associate Safety Director / Portfolio Safety Scientist

Das ist der Job

The position requires a strong understanding of drug safety, clinical development and regulated GxP processes.

Darum lohnt es sich

Background For the Portfolio Clinical Safety team in Basel, we are looking for an experienced Associate Safety Director / Portfolio Safety Scientist to support safety science and pharmacovigilance activities across the development and marketed portfolio.

In this role, you will contribute to early and late-stage development programmes as part of the safety team and provide scientific input into study management, signal evaluation, benefit-risk assessments, regulatory submissions and risk management activities.

General Information Start date: 21.08.2026 Latest possible start date: 21.08.2026 Duration: 12 months Extension: Rather unlikely, but the situation may change Workload: 100% Location: Basel Home Office: Full office presence preferred during the first three months for training, afterwards hybrid model Travel: No Working hours: Standard Team size: 2 to 5 Safety Scientists Department: PDS/CSC/PCS - Portfolio Clinical Safety Basel Tasks and Responsibilities Develop and maintain an expert understanding of the safety profile of assigned products or therapy areas.

Act independently as the safety representative within study teams and clinical safety-related activities.

Strong process improvement mindset and experience in cross‑functional global teams. #J-18808-Ljbffr You will work with a high level of independence, manage safety-related responsibilities across assigned products or therapy areas and collaborate closely with global internal and external stakeholders.

Understand the relevant strategic context, including disease area, competitor safety profiles and mechanism of action. Manage individual and aggregate safety reporting activities, including ICSR medical review, DSURs and PBRERs. Support signal detection, signal evaluation and signal management activities.

Review safety assessments, drug safety reports and safety-related responses to regulatory authority requests. Contribute to the development and execution of product safety strategies.

Take ownership of risk management deliverables, including CCDS, Reference Safety Information, labelling updates, Investigator’s Brochure content, risk communications and Risk Management Plans. Review clinical protocols, clinical study reports, informed consent forms, Investigator’s Brochures and other study-related documents.

Ensure study documents are aligned with the overall safety strategy and appropriate risk communication. Prepare and contribute to safety sections of regulatory submissions, including INDs, NDAs, MAAs, variations and renewals.

Participate in Drug Monitoring Committees, internal monitoring committees and other governance forums where safety input is required. Support the presentation of important safety topics to Drug Safety Committees, Development Review Committees and other internal or external review bodies.

Take responsibility for specialised PCS roles, such as subject matter expert, business process owner or safety committee member. Support non-molecule projects, due diligence evaluations and other safety-related initiatives when required. Coordinate and collaborate with vendors supporting Safety Science activities.

Work effectively with global and remote stakeholders in a cross‑functional environment. Apply complex data analysis and statistical methods to evaluate, interpret and present safety data clearly. Contribute to process improvements within Safety Science and related regulated processes.

Required Profile Qualified healthcare professional or Life Sciences graduate. At least 4 years of experience in drug development within the pharmaceutical industry or a closely related environment. Minimum 3 years of experience in drug safety, pharmacovigilance or a closely related safety function.

Experience at Associate Safety Director level is required. Strong knowledge of safety science, pharmacovigilance, GxP requirements and the end‑to‑end clinical trial lifecycle. Proven experience with signal detection, risk management, aggregate reporting and safety documentation.

Ability to work independently with minimal supervision and strong self‑leadership. Strong analytical skills, including the ability to extract, analyse and interpret data from safety databases. Good MS Office skills, especially Excel, Word and PowerPoint. Excellent written and verbal communication skills.

Strong presentation skills with the ability to summarise complex safety topics, key risks and decision points clearly. Fluent English, both written and spoken. Nice to Have Postgraduate qualification such as PhD, MSc, PharmD or another relevant healthcare or life sciences qualification.

Experience as subject matter expert, business process owner or safety committee member. Experience working with vendors in a safety science or pharmacovigilance environment.