Senior Safety Professional
hace 2 días
Role Summary
This role will have you working in the world's largest and most comprehensive clinical research organisation, powered by healthcare intelligence.
You will be partnering with a pharmaceutical company dedicated to discovering and developing treatments that improve and save people's lives. You will feel challenged and supported to advance in your professional career while making a true impact.
Key Responsibilities- Receives and processes individual case safety reports (ICSR) from clinical trial, spontaneous and published reports. This includes tracking of received ICSR, entry of ICSR into company or client safety database, and query management.
- Performs consistent coding of diseases, adverse events, and medications according to the project-specific coding conventions in the Safety Database.
- Assesses reportability of ICSRs based on the project-specific Safety Reporting Assessment sheet.
- Submits safety reports to Regulatory Authorities, IRB/ECs, and investigational sites in accordance with relevant legislation and the project-specific contractual agreement.
- Supports the generation of Aggregated Safety Reports (e.g. Development Safety Update Report, IND Annual Report, Periodic Safety Update Reports, and other cumulative safety reports) through data retrieval and other assigned tasks.
- Supports interim data analysis for DMC reviews.
- Receives inquiries from consumers or healthcare professionals in support of marketed products; triages the inquiry as a request for medical information, product quality complaint, and/or adverse event and processes received information in accordance with project specific instructions.
- Bachelor's degree in a health, life sciences, or other relevant field of study.
- The successful candidate will have relevant pharmaceutical industry experience, preferably in pharmacovigilance/drug safety, with knowledge of medical terminology and coding systems.
- All employees must read, write, and speak fluent English and host country language.
We offer a competitive salary of $85,000 per year, along with a range of additional benefits focused on well-being and work-life balance opportunities for you and your family. Our benefits are designed to be competitive within each country.
We value diversity, inclusion, and belonging at ENGINEERINGUK. Our rich diversity makes us more innovative, which helps us better serve our people, patients, customers, and communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation.
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