Senior 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.
As a Senior Clinical Safety Specialist, you will be dedicated to ensuring the safe handling of clinical trials and spontaneous reports from the market.
- Collect, assess, and enter SAEs into the safety database in accordance with Tfs/clients' SOPs and existing demands of the authorities.
- Review and approve 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.
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.
A Bit More About Us
Tfs Healthscience's journey began over 27 years ago in Sweden, in the city of Lund.
As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future.
Bringing together over 800 professionals, Tfs delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.
Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization.
They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction.
By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence.
This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration.
Together we make a difference.
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