Clinical Safety Specialist
hace 1 semana
Tfs Healthscience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and functional service (FSP) solutions.
As a member of our SRS/FSP team, you will be dedicated to one sponsor, an international pharmaceutical company that is an industry leader.
Key Responsibilities- Handling of Serious Adverse Events (SAEs) in clinical trials and spontaneous reports from the market, ensuring collection, assessment, and entry into the safety database in accordance with Tfs Healthscience and client SOPs and existing regulatory demands.
- Review and approval of processed cases and AE/SAE reconciliation.
- Coding of adverse events, medical history, and concomitant medication according to MedDRA and WHO-Drug Dictionary.
- Quality control and approval of coding of adverse events, medical history, and concomitant medication.
- Review and writing of the safety section in clinical study protocols.
- Review of clinical trial reports and Investigational Brochures (IBs) from a safety perspective.
- Writing the safety parts in Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), Investigational New Drug (IND) applications, New Drug Applications (NDAs), and other safety documents.
- Literature search.
- Electronic reporting to EudraVigilance.
- Contribution to plans, instructions, and SOPs for post-approval surveillance.
- Updating of templates for safety handling in specific studies/projects according to relevant SOPs.
- May act as a Project Lead for Safety-only projects.
- Participation in relevant meetings, forwarding information to relevant members of the department or study team members.
- Internal support to other relevant departments.
- Involved in improvement projects with other relevant departments.
Active contribution to the organization and development of routines to enhance the work at Tfs Healthscience. 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 handling and reporting of SAEs in clinical trials and serious as well as non-serious events from the market (pharmacovigilance) and other safety issues.
Requirements- Bachelor's Degree, preferably in life science or nursing; or equivalent.
- 3 years of experience in the position.
- Able to work in a fast-paced environment with changing priorities.
- Understanding of medical terminology and science associated with the assigned drugs and therapeutic areas.
We offer a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment.
You'll be joining a team that values collaboration, innovation, and making a difference in the lives of patients.
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