Safety & PV Coordinator II - Data Management - Budapest
Employer · Syneos Health
Medical records technician
Other health professional
Data entry clerkFull-timeBudapest
Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum. Join our Clinical Solutions team and collaborate with passionate problem solvers to shape solutions that impact patients' lives.
Tasks
- Assists with safety and pharmacovigilance program delivery activities including collection, processing, and reporting of individual cases safety reports (ICSRs)
- Literature screening and review for safety, drug coding, and maintenance of drug dictionary
- Medical Dictionary for Regulatory Activities (MedDRA) coding
- Data management activities which includes cleaning and validation of data, xEVMPD product dictionary, and manual recoding of substance/product terms
- Management of duplicate ICSR cases and quality review of ICSRs
- Substances, Products, Organizations and Referential (SPOR) / Identification of Medicinal Products (IDMP) activities
- Preparation of expedited and periodic safety reports, while adhering to all data privacy guidelines, GCP, GVP, and regulatory guidelines
Conditions & benefits
Career development and progressionSupportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards program.Inclusive cultureCommitted to building an inclusive culture where you can authentically be yourself.