Clinical Safety Specialist
hace 4 semanas
About this role
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
We offer full service-capabilities, resourcing and functional service (FSP) solutions.
As part of our team
You will be dedicated to one sponsor, an international pharmaceutical company that is an industry leader.
Key Responsibilities
- Handling of SAE in clinical trials and spontaneous reports from the market, to ensure collection, assessment and entering into the safety database in accordance with the Tfs/clients' SOPs and existing demands of the authorities.
- Review 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.
- QC and approval of coding of adverse event, medical history and concomitant medication.
- Review and write the safety section in clinical study protocols.
- Review of clinical trial reports/IBs from a safety perspective.
- Write the safety parts in the PSUR/PBRER, DSURs, IND, NDA and other safety documents.
- Literature search.
- Electronic reporting to EudraVigilance.
- Contribute 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.
- Participate in relevant meetings.
- Forward information to relevant members of the department or study team members.
- Provide internal support to other relevant departments.
- Involved in improvement projects with other relevant departments.
About us
We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment.
Our journey
We began over 27 years ago in Sweden, in the city of Lund.
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