Pharmacovigilance Specialist
4 settimane fa
Job Title: Pharmacovigilance Specialist
Job Summary:
We are seeking a highly skilled Pharmacovigilance Specialist to join our team at TFS. As a Pharmacovigilance Specialist, you will be responsible for handling and processing adverse event reports, conducting literature searches, and contributing to the development of safety documents.
Key Responsibilities:
- Handling of SAEs in clinical trials and spontaneous reports from the market
- 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
- QC and approval of coding of adverse events, 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
- Actively contribute 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 handling and reporting of SAEs in clinical trials and serious as well as non-serious events from the market (pharmacovigilance) and other safety issues
- Education and supervision of new Drug Safety personnel
- Participate in marketing activities
Requirements:
- Bachelor's Degree, preferably in life science or nursing; or equivalent
- +2 years of experience in a Pharmacovigilance officer role
- Able to work in a fast-paced environment with changing priorities
- Understand the medical terminology and science associated with the assigned drugs and therapeutic areas
About Us:
TFS 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.
What We Offer:
We provide 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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