Safety & PV Specialist I, Russian Fluent

Syneos Health

Safety & PV Specialist responsible for processing ICSRs and maintaining safety tracking systems at Syneos Health. Collaborating with teams to ensure compliance and quality in pharmacovigilance activities.

Posted 7/28/2026full-timeBelgrade • 🇷🇸 SerbiaJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Safety and Pharmacovigilance, including data entry, coding, and regulatory compliance. Proficient in managing ICSR processing and maintaining safety databases while ensuring adherence to SOPs and regulatory guidelines.

Highest-signal resume keywords

Safety Database SystemsICSR ProcessingMedDRA CodingRegulatory ComplianceRussian Language Skill

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data EntryEvent CodingMedical TerminologyLiterature ScreeningQuality ReviewRegulatory ReportingPharmacovigilanceClinical Trial ProcessSafety SubmissionsDrug Development Process

Soft Skills

Excellent CommunicationInterpersonal SkillsOrganizational SkillsDetail OrientedAbility to Work Independently

Tools & Technologies

Microsoft Office SuiteVisioOutlookTeam ShareSafety Tracking Systems

Industry Keywords

GCPICH GuidelinesGVPSPORIDMPSOPsWork InstructionsClinical TrialsPost-Marketing SafetyPharmacovigilance System Master File

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 ICSR as required
Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required
Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability
Enters data into safety database
Codes events, medical history, concomitant medications, and tests
Compiles complete narrative summaries
Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved
Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements
Maintains safety tracking for assigned activities
Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required
Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA
Manual recoding of un-recoded product and substance terms arises from ICSRs
Identification and management of duplicate ICSRs
Activities related to SPOR / IDMP
Quality review of ICSRs
Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate
Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process
Fosters constructive and professional working relationships with all project team members, internal and external
Participates in audits as required/appropriate
Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities

Requirements

What you’ll need

Bachelor’s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience
RUSSIAN LANGUAGE SKILL IS MUST-HAVE
Approx 2 yrs of experience in Safety & Pharmacovigilance is required in case processing or safety submissions
Safety Database systems and knowledge of medical terminology required
Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance
Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), Team Share (or another management/shared content/workspace)
Ability to work independently and in a team environment
Excellent communication and interpersonal skills, both written and spoken
Good organizational skills with proven ability to prioritize and work on multiple tasks and projects
Detail oriented with a high degree of accuracy and ability to meet deadlines

Benefits

Comp & perks

We are passionate about developing our people, through career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition and total rewards program
Committed to building an inclusive culture