Clinical Safety Manager
2 maanden geleden
QPS Netherlands B.V. in Groningen is part of an international organization and conducts drug research on behalf of international pharmaceutical and biotechnological companies. We are seeking an experienced Clinical Safety Manager to lead and oversee the Safety Management process within clinical trials. In this role, you will be responsible for establishing safety reporting procedures, managing pharmacovigilance services, and serving as the main point of contact for sponsors, clinical teams, and subcontractors.
This remote role may be filled in the US, in Austria or in the Netherlands.
What will you do?
Oversee the entire Clinical Safety Management process for clinical trialsAct as the primary contact for sponsors, clinical project managers, and the QPS Safety Unit teamCollaborate with the finance team to manage project setup, budgeting, and invoicingEnsure compliance with safety reporting requirements, including Eudravigilance registrationDevelop and maintain Clinical Safety Management Plans, safety databases, and related documentsLead clinical safety team meetings and ensure effective communication with all involved partiesWork Location
This job may be 100% home-office based (please ask to see Telecommuting Policy for full details).Who are you?
Strong knowledge of international safety reporting regulations and guidelines (GCP, Eudravigilance)Working knowledge of Safety Reporting requirements within clinical studiesProven experience in clinical trials or CROsExcellent organizational and communication skills (must have business level English skills)Possesses strong analytical thinking – demonstrates the ability to thoroughly research, evaluate, and apply critical information effectivelyExhibits strong attention to standards and impact – thinks things through and consistently demonstrates thoroughness and accuracy in their workUniversity degree in a relevant discipline or equivalent experience
What do we offer?
This is an opportunity to take on a pivotal role in a leading organization where your leadership will shape our clinical safety efforts. If you’re ready to bring your expertise to a dynamic team that values innovation and quality, we would love to hear from you -
Vaccination protocol
As an employee of QPS you are expected to participate in the vaccination program of QPS for Health purposes. This vaccination program includes a Hepatitis B vaccination. By applying for this job, you automatically accept to participate in this vaccination program when hired. For details you can ask the HR department.
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