Description
Syneos Health is seeking a Safety & PV Specialist I (Data Management) to join their team in hybrid Sofia.
The successful candidate will assist with safety, pharmacovigilance, and regulatory activities, including MedDRA coding, data management activities such as data cleaning, validation, mapping, enrichment, and reporting, while adhering to data privacy guidelines, GCP, GVP, and regulatory guidelines.
Key Responsibilities:
- Review existing system data against reference sources
- Identify discrepancies and update records per project regulatory guidelines
- Analyze data based on BU reference standards
- Focus on accurate processing and maintenance of structured data
- Update incomplete fields, create or submit missing information, and perform general data entry and quality improvement
Qualifications:
- Bachelor's degree in a scientific field (Life Sciences degree)
- 2+ years of experience in a scientific/clinical research background with experience in data handling, data validation, and regulatory processes
- English fluency to collaborate with regional and global teams
The company offers a range of benefits, including career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards program.