Associate Safety Director / Portfolio Safety Scientist

Associate Safety Director / Portfolio Safety Scientist

Location: Basel, Switzerland
Workload: 100%
Start Date: ASAP
Duration: 12 months (extension possible)
Department: PDS / CSC / PCS - Portfolio Clinical Safety Basel

About the Role

As an Associate Safety Director / Portfolio Safety Scientist, you will play a key role in ensuring the safety of Roche's drug portfolio throughout all stages of development and post-marketing. You will act as the scientific expert for product safety, overseeing the identification, evaluation, and management of safety risks, and ensuring compliance with global pharmacovigilance regulations.

You will collaborate closely with cross-functional teams and regulatory authorities to ensure that all safety-related activities meet Roche's high standards of scientific integrity and patient safety.

Your Key Responsibilities

• Develop and maintain an in-depth understanding of the safety profile and benefit-risk balance of assigned products and therapeutic areas.

• Perform individual and aggregate case evaluations (ICSR review, DSUR, PBRER preparation).

• Conduct signal detection, evaluation, and management activities to identify and assess new or emerging safety risks.

• Lead risk management processes, including the preparation and maintenance of CCDS, labeling documents, Investigator's Brochure (IB), and Risk Management Plans (RMP).

• Contribute to and review clinical study protocols, study reports, informed consent forms (ICF), and other key clinical documents to ensure alignment with safety strategy and regulatory expectations.

• Support regulatory submissions (IND, NDA, MAA, variations, renewals) with high-quality safety documentation and scientific input.

• Represent Safety Science in cross-functional teams, governance committees, and external safety discussions as needed.

• Provide scientific input to internal safety committees (e.g., Drug Safety Committee, Development Review Committee).

• Collaborate with global partners and vendors involved in Safety Science activities.

• Contribute to continuous improvement initiatives and act as subject matter expert or business process owner within PCS.

Who You Are

• Education: Qualified healthcare or life sciences professional (MD, PharmD, PhD, MSc, or equivalent).

• Experience: Minimum of 4 years in drug development, including at least 3 years in drug safety/pharmacovigilance.

• Expertise:

• Strong understanding of GxP and global pharmacovigilance regulations.

• Proven experience in signal detection, risk management, and benefit-risk assessment.

• Skilled in preparing regulatory documents and safety reports.

Technical Skills:

Proficient in Excel, Word, PowerPoint.

Comfortable extracting and analyzing data from safety databases.

Languages: Fluent in English (written and verbal).

Soft Skills:

Excellent communication and presentation skills.

Analytical, detail-oriented, and self-motivated.

Strong team player who thrives in a cross-functional, global environment.

Additional Information

• Workplace: Basel (Hybrid after initial training period of approx. 3 months on-site)

• Travel: Not required

• Team Size: 2-5 Safety Scientists

• Work Hours: Standard business hours

• Contract: 12 months, with possible extension depending on project needs

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