Associate Safety Director(F/m/d)

**Project**:
For our customer a big pharmaceutical company in Basel we are looking for a highly qualified Associate Safety Director.

**Background**:
Portfolio Safety Scientists (PCS-Sci) provide safety science and pharmacovigilance support to molecules across the Roche portfolio. As a group, they are responsible for all aspects of safety science/pharmacovigilance, with accountability being held by PCS leadership and experts or SSLs (Safety Strategy Program Leaders) depending on the deliverable/activity.

**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.
- 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.
May be expected to support non-molecule projects, due diligence evaluations and other projects as needed.
- Responsible for coordination and collaboration with vendors servicing Safety Science.
Understanding of GxP and regulated processes and end to end clinical trial lifecycle.
- Strong orientation towards process improvement and cross-functional teamwork.
- Effectively work with remote partners on a global team.
- Excellent communication skills, both written and verbal.
- Strong presentation skills, effective at summarizing and presenting the key considerations and decision points.

**Must Haves**:

- Qualified healthcare professional or Life Sciences graduate. Preferred Qualifications: A relevant postgraduate qualification (e.g. PHD/MSc in a Life sciences discipline; PharmD or other post-graduate health professional qualifications) would be advantageous
- Work Experience 4 or more years of drug development experience in the pharmaceutical or related industry
- At least 3 years in drug safety/PV or a closely related field
- Minimum level required Associate Safety Director
- Language Skills: Fluent in English, both written and verbal

**Reference Nr.: 924476**
**Role: Associate Safety Director**
**Industry: Pharma**
**Workplace: Basel**
**Pensum: 100%**
**Home Office: During the first three months full office presence would be appreciated for training purposes after Hybrid**
**Start: ASAP (Latest Possible Start Date: End of Feb/March, 2026)**
**Duration: 12++**
**Deadline: 14/10/2025**

**Job Type**: 100%

Work Location: On the road