Clinical Safety Specialist (m/w/d)
London, United Kingdom; Mainz, Germany; Munich, Germany | full time | Job ID:9160
As a Clinical Safety Specialist, you will support the execution of clinical safety and pharmacovigilance activities throughout the lifecycle of clinical trials. You will contribute to safety case processing, regulatory reporting, documentation, and periodic analyses of safety data.
Contribute to clinical safety planning activities during trial set-up by supporting the preparation of safety management plans, charters, and reconciliation processes. Support in the coordination of cross-functional teams to enable readiness for safety data handling and reporting. Contribute to meeting organization (e.g. SMT, IRC, SRC) ensuring documentation of decisions and follow-up activities under the guidance of the Safety Manager.
May take on the day-to-day clinical safety responsibilities for an assigned clinical trial under the supervision of a Clinical Safety Scientist of Clinical Safety Manager.
Perform and support end-to-end case processing activities including data entry, case triage, MedDRA coding, causality and seriousness assessments, and safety query generation. Support the coordination of case exchanges with partners and contribute to the tracking of compliance metrics for safety reports.
Contribute to the preparation and quality review of SUSAR submissions, DSURs, line listings, and other periodic reports in accordance with global requirements and regional timelines.
Maintain accurate records within the safety database, support database testing activities (e.g., user acceptance testing), and assist with system issue resolution and enhancement requests.
Perform SAE reconciliation activities at the trial level, ensuring completeness and accuracy across clinical and safety databases.
Work closely with Safety Physicians and Safety Scientists to support the medical review of safety cases, contribute to safety data interpretation, and ensure consistency and accuracy in trial-specific documents such as clinical trial protocols and regulatory responses.
May participate in routine signal detection activities by compiling and formatting data for safety reviews under the supervision of the Clinical Safety Scientist or Safety Physician.
Bachelor’s Degree in life sciences, pharmacy, public health or a related field (postgraduate qualification preferred)
Minimum 2 years of experience in clinical research and pharmacovigilance within the pharmaceutical, biotech, or CRO industry
Minimum 1 year of case processing experience
Knowledge of applicable regulatory, GCP, and GVP requirements in major geographies
Solid project management and cross-functional collaboration skills
Fluent in written and spoken English
It's our priority to support you:
Your flexibility: flexible hours | vacation account
Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
Your health and lifestyle: Company bike
Your mobility: Job ticket | Deutschlandticket
Your life phases: Employer-funded pension | Childcare