
Drug Safety Expert
2 days ago
About this Role
TFS HealthScience is a Contract Research Organization (CRO) that provides full service-capabilities, resourcing and functional service (FSP) solutions to biotechnology and pharmaceutical companies. We partner with our clients throughout their entire clinical development journey.
The QPPV/Safety Manager is responsible for management of Drug Safety and works according to company policies, SOPs and regulatory requirements. This includes:
- Holding QPPV responsibilities for some customers
- Acting as a Project Manager for Post marketing Safety-only projects
- Writing safety parts in PSUR/PBRER, RMP other safety documents
- Literature search
- Handling of spontaneous adverse event reports from the market
- Reviewing and approval of processed cases and AE/SAE reconciliation
- Coding of adverse event, medical history and concomitant medication according to MedDRA and WHO-Drug Dictionary
- Electronic reporting to EudraVigilance
- Contributing to plans/instructions and SOPs for post approval surveillance
- Updating of templates for safety handling in specific studies/projects according to relevant SOPs
- Participating in relevant meetings
- Providing internal support to other relevant departments
- Involved in improvement projects with other relevant departments
- Actively contributing to the organization and development of routines to enhance the work at TFS
- Validation of computer applications specific for the department with respect to drug safety requirements
- Being well-informed and updated on laws, directives and guidelines concerning pharmacovigilance and other safety issues
- Education and supervision of new Drug Safety personnel
- Participating in marketing activities
As a member of our team, you will have opportunities for personal and professional growth in a rewarding environment.
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