Safety & PV Specialist I

Syneos Health

Assist in safety and pharmacovigilance program delivery activities for drug development at Syneos Health. Engage in data management, literature review, and submission processes to support clinical trials.

Posted 7/1/2026full-timeSofia • 🇧🇬 BulgariaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in pharmacovigilance and safety reporting, including ICSR case processing, MedDRA coding, and adherence to regulatory guidelines. Proficient in data management and literature screening, with strong organizational and communication skills.

Highest-signal resume keywords

ICSR Case ProcessingMedDRA CodingGCP ComplianceData ManagementClinical Trial Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

ICSR ProcessingMedDRA CodingData CleaningData ValidationMedical TerminologyRegulatory ReportabilitySafety ReportingTrial Master File ManagementPharmacovigilanceLiterature Screening

Soft Skills

Excellent CommunicationInterpersonal SkillsOrganizational SkillsDetail OrientedAbility to Prioritize

Tools & Technologies

Microsoft Office SuiteVisioOutlookTeam ShareInternet

Industry Keywords

PharmacovigilanceSafety ReportsGVPICHClinical TrialsIDMPData Privacy GuidelinesPost-Marketing Safety

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

assist with safety and pharmacovigilance program delivery activities including collection, processing, and reporting of individual cases safety reports (ICSRs)
literature screening for safety, drug coding, maintenance of drug dictionary, MedDRA coding
data management activities including cleaning and validation of data
identification of Medicinal Products (IDMP) activities and preparation of expedited and periodic safety reports
adheres to data privacy guidelines, GCP, GVP, regulatory guidelines, company and project/program-specific procedures
enter information into PVG quality and tracking systems for receipt and tracking ICSR
assist in the processing of ICSRs according to SOPs
triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory reportability
maintains safety tracking for assigned activities
performs literature screening and review for safety
ensures all relevant documents are submitted to the Trial Master File (TMF)
participates in audits as required/appropriate

Requirements

What you’ll need

Bachelor’s Degree in life science, registered nurse, pharmacist or equivalent combination of education and experience
3+ years of experience in ICSR case processing
Advanced MedDRA coding training
knowledge of medical terminology
Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations
Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), Team Share (or another management/shared content/workspace) and internet
Excellent communication and interpersonal skills, both written and spoken
good English level
Good organizational skills with proven ability to prioritize and work on multiple tasks and projects
Detail oriented with a high degree of accuracy

Benefits

Comp & perks

career development and progression
supportive and engaged line management
technical and therapeutic area training
peer recognition
total rewards program
building an inclusive culture