Drug Safety Scientist

Our client is an innovative biotech company based in the Basel region-one of Europe's leading life science hubs. With a highly experienced team and a strong development pipeline, they focus on delivering impactful small‑molecule therapies that can transform patient care. The company operates across the full value chain, from early research to global commercialization, and partners with industry leaders to maximize product value.

We are supporting this organization in identifying a motivated Drug Safety Scientist to strengthen their Global Drug Safety function and contribute to patient safety across the entire product lifecycle.

This position is ideal for someone who is passionate about pharmacovigilance, enjoys cross‑functional collaboration, and is eager to grow within a science‑driven environment.

Job Responsibilities

Safety Signal Tracking and Management

• Support Drug Safety Physicians in the medical safety evaluation of identified signals and in drafting responses to Health Authority safety queries.
• Act as the lead for safety signal tracking and documentation, ensuring clear oversight, timely follow‑up, and completion of safety actions.
• Monitor regulatory sources such as PRAC meeting outputs and other relevant publications, informing the safety leadership team of any findings related to the company's portfolio, therapeutic classes, or competitors.

Periodic Safety Reporting & Medical Writing

• Coordinate planning, scheduling, and allocation of responsibilities for aggregated regulatory safety reports (e.g., DSUR, PBRER).
• Work closely with cross‑functional partners (Regulatory Affairs, Clinical Pharmacology, Clinical Science, Medical Affairs) to collect accurate safety information on time.
• Act as lead author-together with the assigned Drug Safety Physician-on periodic safety reports and other safety analyses.
• Review relevant scientific literature for inclusion in periodic reports.
• Collaborate with Regulatory Affairs to ensure timely submission of all periodic safety deliverables.
• Support preparation of additional regulatory documents such as ISS, reference safety information for Investigator Brochures, and EU Risk Management Plans.

Additional Responsibilities

• Provide mentoring or guidance to junior Safety Scientists when appropriate.
• Act as an internal expert on MedDRA, contributing to data retrieval specifications and maintenance.
• Ensure awareness of evolving global pharmacovigilance requirements and contribute to updating SOPs and work instructions.
• Serve as subject matter expert during audits, inspections, and process improvement initiatives related to signal management and periodic reporting.

Candidate Requirements

• University degree in a life science or health‑related discipline (e.g., Pharmacy, Nursing, M.Sc., Ph.D.).
• Minimum 10 years of pharmacovigilance experience within the pharmaceutical/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 written communication skills and proven medical writing expertise.
• Strong interpersonal, analytical, and problem‑solving skills.
• Ability to manage timelines, work independently, and coordinate cross‑functional inputs.
• Fluent in English (written and spoken).
• Advanced understanding of MedDRA, SMQs, WHO Drug Dictionary, and safety data groupings.
• Exceptional attention to detail and strong analytical thinking.

Please note, only those with the right to work in Switzerland should apply. Those shortlisted shall be contacted regarding the position.