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Wir suchen eine:n Senior Associate Scientist / Analytical Development (m/w/d) – Basel
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. The position requires a strong understanding of drug safety, clinical development and regulated GxP processes.
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.
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.
- 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.
- Act independently as the safety representative within study teams and clinical safety-related activities.
- 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.
- Strong process improvement mindset and experience in cross-functional global teams.