Associate safety director

Associate Safety Director (m/f/d) (LSW)- Drug safety/pharmacovigilance/ English

Reference Nr.: 925025

Industrie: Pharma

Workplace: Basel

Pensum: 100%

Start: 21.08.2026

Duration: 12 months ++

Deadline: 24.06.2026

Job Overview

Portfolio Safety Scientists (PCS‑Sci) provide safety science and pharmacovigilance support across the Roche portfolio. As a member of the safety team, the Associate Safety Director works in early and late‑phase development activities, providing essential safety oversight and input into study management, signal evaluation, benefit‑risk assessment, and safety risk management in the post‑market setting. The role requires working with minimal supervision and strong self‑leadership.

Responsibilities

• Develop and maintain an expert understanding of the safety profile of assigned product(s) and their therapeutic areas, including disease context, competitor safety profiles, and mechanism of action.
• Manage individual and aggregate case reporting activities, including ICSR case management (medical review) and aggregate reporting such as DSUR and PBRER.
• Perform signal detection and management activities, contributing to strategy and review of safety assessments and drug safety reports for signals or issues, including product quality concerns and regulatory authority requests.
• Provide expert contribution to the development of the product safety strategy and take independent responsibility for risk management activities, including preparation and maintenance of CCDS, labeling documents (including IB), risk communications, and RMP.
• Review clinical protocols, study reports, Investigator's Brochure (IB), informed consent form (ICF) and related documents to ensure alignment with the safety strategy and appropriateness of risk management strategies and communication.
• Take responsibility for safety science contributions to regulatory authority submissions (IND, NDA, MAA, variations, renewals, etc.).
• Prepare and maintain 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), Internal Monitoring Committees (IMC), and other internal and external review and governance committees as applicable.
• Support presentation of important safety issues to the Drug Safety Committee (DSC), Development Review Committee (DRC), and other relevant committees.
• Act independently to manage safety responsibilities on study teams and in activities supporting clinical safety.
• Assume specialized roles with PCS, such as functional business process owner, subject matter expert, safety committee member, and support non‑molecule projects, due diligence evaluations, and other projects as needed.
• Coordinate and collaborate with vendors servicing Safety Science, ensuring understanding of GxP and regulated processes throughout the end‑to‑end clinical trial lifecycle.

Qualifications

• Qualified healthcare professional or Life Sciences graduate; a postgraduate qualification (e.g., PhD/MSc in a Life Sciences discipline, PharmD, or other post‑graduate health professional degree) is advantageous.
• Minimum 4 years of drug development experience in the pharmaceutical or related industry, with at least 3 years in drug safety/pharmacovigilance or a closely related field.
• IT/Tool skills: good proficiency in Excel, Word, PowerPoint, and ability to extract data from the Safety Database and apply complex data analysis.
• Fluent in English, both written and verbal.
• Minimum level required: Associate Safety Director.