Drug Safety Scientist

We are currently supporting an innovative biotech company in the Basel region in their search for a motivated Drug Safety Scientist. This is an exciting opportunity to contribute to global patient safety and grow your career within a science‑driven, rapidly advancing organization.

You will be responsible for:

Safety Signal Tracking & Management

• Supporting Drug Safety Physicians in the medical evaluation of identified safety signals and in drafting responses to Health Authority queries
• Acting as the lead for signal tracking and documentation, ensuring oversight, timely follow‑up, and completion of safety actions
• Monitoring regulatory sources (e.g., PRAC meeting outputs, relevant publications) and informing the safety leadership team about findings related to internal products, therapeutic areas, or competitors

Periodic Safety Reporting & Medical Writing

• Coordinating planning, scheduling, and task allocation for aggregated safety reports (e.g., DSUR, PBRER)
• Collaborating with cross‑functional teams (Regulatory Affairs, Clinical Pharmacology, Clinical Science, Medical Affairs) to collect accurate safety information
• Serving as lead author-together with the assigned Drug Safety Physician-on periodic safety reports and other safety analyses
• Reviewing relevant scientific literature for inclusion in periodic reports
• Working with Regulatory Affairs to ensure timely submission of all periodic safety deliverables
• Supporting the preparation of additional regulatory documents such as ISS, reference safety information for Investigator Brochures, and EU Risk Management Plans

Additional Responsibilities

• Providing guidance or mentoring to junior Safety Scientists
• Acting as an internal expert on MedDRA, contributing to data retrieval specifications and dictionary maintenance
• Staying informed about evolving global pharmacovigilance requirements and contributing to SOP and work‑instruction updates
• Serving as a subject matter expert during audits, inspections, and process improvement initiatives related to signal management and periodic reporting

An ideal candidate should have the following qualifications:

• University degree in a life science or health-related discipline (e.g., Pharmacy, Nursing, M.Sc., Ph.D.)
• Minimum 10 years of pharmacovigilance experience in the pharmaceutical or biotech industry
• At least 3 years of experience authoring regulatory safety documents (DSURs, PBRERs/PSURs, ISS, clinical study reports, etc.)
• Strong knowledge of clinical trial and post‑marketing safety regulations (ICH, EU, FDA)
• Excellent scientific writing and communication skills
• Strong analytical, interpersonal, and problem‑solving abilities
• Ability to manage timelines, work independently, and coordinate cross‑functional inputs
• Fluent English (written and spoken)
• Advanced understanding of MedDRA, SMQs, WHO Drug Dictionary, and safety data groupings
• Exceptional attention to detail and strong analytical thinking

What We Offer:

• Competitive compensation
• Opportunity to contribute to impactful therapies and grow within a science‑driven environment

If this opportunity interests you, please apply!

NOTE: Only shortlisted candidates will be contacted. Only candidates with the right to work in Switzerland can be considered (e.g., EU citizens or holders of a valid Swiss work permit).