Drug Safety Case Manager (m/f/d)

CTC Resourcing Solutions AG in Basel, CH, seeks a Junior Drug Safety Case Manager for an onsite contract role. The position involves managing safety case lifecycles in clinical trials, ensuring regulatory compliance, and collaborating with cross-functional teams.

This role focuses on overseeing the full lifecycle of safety cases within clinical trials, ensuring timely and accurate reporting to regulatory bodies and internal stakeholders. The position supports drug safety operations by maintaining data integrity and compliance with regulatory standards.

Responsibilities

• Handle all stages of safety case management, including triage, data input, adverse event coding, narrative creation, quality checks, and submission of urgent safety reports.
• Track daily workloads and ensure adherence to regulatory deadlines and internal quality benchmarks.
• Spot gaps in case data and coordinate follow-up with relevant parties to complete information.
• Represent drug safety in clinical trial team meetings for assigned studies.
• Work with drug safety physicians and cross-functional teams on safety-related trial activities.
• Assist in aligning clinical and safety databases with data management teams.
• Organize safety report submissions to regulatory authorities, investigators, ethics committees, and other stakeholders.
• Adhere to SOPs, quality standards, governance policies, and regulatory requirements.
• Participate in process improvements and support data migration or cleaning tasks as needed.

Requirements

• Must hold a Swiss working/residency permit or be a Swiss/EU citizen.
• Bachelor’s degree in Life Sciences or a related scientific field is required.
• 1–2 years of experience in drug safety, pharmacovigilance, or clinical/safety data management.
• Solid grasp of medical terminology and safety reporting procedures.
• Familiarity with medical coding systems like MedDRA.
• Strong organizational, communication, and problem-solving abilities.
• Capable of handling pressure and managing multiple priorities under tight schedules.
• Fluent in English, both written and spoken.

Nice to have

• A Master’s degree or equivalent is considered beneficial.
• Familiarity with EU and US pharmacovigilance regulations is advantageous.