Safety & PV Specialist I, Data Management

Syneos Health

. Assist with safety, pharmacovigilance, and regulatory activities .

Posted 9/17/2026full-timeSofia • BulgariaJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in safety, pharmacovigilance, and regulatory activities, with a strong focus on data handling, validation, and adherence to Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP). Proficient in MedDRA coding and data cleansing processes to ensure compliance with regulatory guidelines.

Highest-signal resume keywords

MedDRA CodingData ValidationGood Clinical Practice (GCP)Good Pharmacovigilance Practice (GVP)Data Cleansing

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data HandlingData MappingData EnrichmentData AnalysisData EntryQuality ImprovementRegulatory ProcessesData Privacy GuidelinesStructured Data MaintenanceDiscrepancy Identification

Soft Skills

CollaborationAttention to DetailProblem-SolvingCommunication

Tools & Technologies

XEVMPDSPOR/IDMP

Industry Keywords

PharmacovigilanceRegulatory ActivitiesClinical ResearchLife SciencesData Privacy

About the role

Key responsibilities & impact

Assist with safety, pharmacovigilance, and regulatory activities
Perform Medical Dictionary for Regulatory Activities (MedDRA) coding
Clean and validate xEVMPD product dictionary, SPOR/IDMP data
Conduct data cleansing, mapping, enrichment, and validation
Review existing system data against reference sources
Identify discrepancies and update records according to project regulatory guidelines
Analyze data based on BU reference standards
Process and maintain structured data accurately
Update incomplete fields and create or submit missing information
Perform general data entry and quality improvement
Filter, migrate, analyze, report, file, or publish data and information as needed

Requirements

What you’ll need

Bachelor’s degree in scientific field (Life Sciences degree)
2+ years in scientific/clinical research background with experience in Data handling/Data validation/Regulatory processes
English fluency to collaborate with regional and global teams
Adherence to data privacy guidelines, Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), regulatory guidelines, and company/project-specific procedures
Equivalent experience, skills, and/or education may be considered

Benefits

Comp & perks

Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition
Total rewards program
Inclusive culture
Reasonable accommodations, when appropriate, for employees or applicants with disabilities