As a clinical safety specialist you will work with other members of the MCO Clinical Safety team located around the world, Chinical Operations, Data Management, Quality Assurance and Regulatory Affairs to manage death and adverse event reporting in compliance with applicable regulatory standards and internal requirements.
Review and triaging clinical trial deaths and adverse events including serious adverse events
Conduct Case Management in the Clinical Safety Database
Interact with investigational sites and field monitors to obtain additional pertinent information as indicated
Work with the clinical project team to ensure consistency in the assessment, recording and coding of clinical safety events
Work with Regulatory Affairs, Clinical Operations and Field Assurance to ensure timely reporting including expedited and annual reporting and other documents as needed
Ensures appropriate distribution and notification to appropriate personnel, partners, and clinical centers for protocols
Liaison for safety-related questions
Write Clinical Safety plan for assigned protocols
Assist with preparation of assigned section of safety reports for annual reports, clinical study reports, investigator brochure updates, and other documents as required
Collaborate with data management and other departments on the development of case report forms, study specific safety reports and other study specifc forms
Assist with the writing of safety sections of clinical protocols and may present safety monitoring at investigator meetings
Over het bedrijf
A large global multinational in the South of Holland.
For this position in Maastricht we're looking for a proffesional with good written, oral and interpersonal communication skills including knowledge of medical terminology.
2 years safety experience
Proficient with MS Office products, word processing, spreadsheets ect.
High attention to detail and accuracy and ability to manage multiple tasks
Good prioritization and organizational skills and excellent problem solving skills
Works effectively on cross-functinal teams
We offer you a professional, international, dynamical and high quality working environment, where personal development is stimulated and personal initiatives are encouraged. Your development plan will challenge you to further develop your personal skills and competencies, to build your career within our global organization.
Gross salary: €2900 - €3500 a month (40-hour work week). The salary depends on your age and years of experience in a simular role.
8% holiday payment and 24 holidays, based on worked hours
Travel expenses of €0.19 cent pro km.
If you feel the Clinical Safety Specialist is of interest and it falls within your skills set, then please feel free to start your application by applying below. For further questions please contact Jacky Timmermans - Schmeits via email@example.com or 06-46928761
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