Safety & PV Specialist I

Syneos Health

Safety and Pharmacovigilance Specialist processing ICSRs, coding medical safety data, and supporting regulatory reporting for Syneos Health. Hybrid role in Budapest within a global life sciences services organization.

Posted 8/4/2026full-timeBudapest • 🇭🇺 HungaryMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in pharmacovigilance processes, including data entry, coding, and regulatory compliance. Proficient in safety database systems and knowledgeable in ICH GCP, GVP, and safety regulations.

Highest-signal resume keywords

PharmacovigilanceSafety Database SystemsICH GCP KnowledgeData Entry and CodingClinical Trial Processes

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data EntryCoding EventsMedical TerminologyRegulatory ReportabilityLiterature ScreeningDrug CodingMedDRA CodingQuality ReviewSafety ReportingSPOR / IDMP Activities

Soft Skills

Excellent CommunicationInterpersonal SkillsOrganizational SkillsDetail OrientationAbility to Work Independently

Tools & Technologies

Microsoft Office SuiteVisioOutlookTeam ShareSafety Tracking Systems

Certifications & Qualifications

Bachelor’s Degree in Life ScienceRegistered NursePharmacist

Industry Keywords

Pharmacovigilance RegulationsClinical TrialsPost-Marketing SafetySOPsGVP

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Enter information into PVG quality and tracking systems for receipt and tracking of ICSRs
Assist with processing ICSRs according to SOPs and project/program-specific safety plans
Triage ICSRs and evaluate data for completeness, accuracy, and regulatory reportability
Enter data into the safety database
Code events, medical history, concomitant medications, and tests
Compile complete narrative summaries
Identify information to query and follow up until queries are satisfactorily resolved
Assist in generating timely, consistent, and accurate expedited reports
Maintain safety tracking for assigned activities
Perform literature screening and review for safety
Perform drug coding and maintain the drug dictionary and MedDRA coding
Validate and submit xEVMPD product records, including coding indication terms using MedDRA
Manually recode un-recoded product and substance terms from ICSRs
Identify and manage duplicate ICSRs
Perform activities related to SPOR / IDMP
Conduct quality reviews of ICSRs
Submit relevant documents to the Trial Master File and Pharmacovigilance System Master File
Maintain compliance with SOPs, WIs, global regulations, GCP, ICH, GVP, project plans, and the drug development process
Foster professional working relationships with project team members
Participate in audits as required
Apply safety reporting regulatory intelligence to safety reporting activities

Requirements

What you’ll need

Bachelor’s Degree in life science, registered nurse, pharmacist, or equivalent combination of education and experience
Safety Database systems and medical terminology knowledge
Good understanding of Phase II–IV clinical trial processes and/or post-marketing safety requirements
Knowledge of ICH GCP, GVP, and safety/pharmacovigilance regulations
Proficiency in Microsoft Office Suite, Visio, Outlook, Team Share, and internet tools
Ability to work independently and in a team environment
Excellent written and spoken communication and interpersonal skills
Good organizational skills and ability to prioritize multiple tasks and projects
Detail orientation and high degree of accuracy
Ability to meet deadlines

Benefits

Comp & perks

Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition and total rewards program
Inclusive culture
Comprehensive resources including emerging technologies, data, science and knowledge sharing
Collaboration with diverse expert teams
Exposure to career paths and employment opportunities