Safety Specialist I

Syneos Health

Safety Specialist processing individual case safety reports and regulatory submissions for Syneos Health’s biopharmaceutical clients. Supporting clinical-trial and post-marketing pharmacovigilance activities across Mexico and Argentina.

Posted 8/12/2026full-timeBuenos Aires • 🇦🇷 ArgentinaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in pharmacovigilance processes, including ICSR processing, safety database management, and compliance with regulatory standards such as ICH GCP and GVP. Proficient in data entry, quality review, and maintaining accurate safety tracking while fostering collaborative relationships within project teams.

Highest-signal resume keywords

Pharmacovigilance RegulationsICSR ProcessingSafety Database ManagementICH GCP KnowledgeMedical Terminology

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data EntryQuality ReviewEvent CodingLiterature ScreeningRegulatory Reportability EvaluationSafety TrackingNarrative Summaries CompilationSPOR / IDMP ActivitiesXEVMPD Product Records ValidationPhase II-IV Clinical Trial Processes

Soft Skills

Excellent Communication SkillsInterpersonal SkillsOrganizational SkillsDetail OrientationAbility to Work Independently

Tools & Technologies

Microsoft Office SuiteVisioOutlookTeam ShareSafety Database Systems

Industry Keywords

SOPsGVPDrug Development ProcessGlobal Drug RegulationsPost-Marketing Safety Requirements

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 ICSR
Assist in 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, tests, indications, products, and substances
Compile complete narrative summaries
Identify information to query and follow up until queries are satisfactorily resolved
Assist with timely, consistent, and accurate expedited safety reporting
Maintain safety tracking for assigned activities
Perform literature screening and review for safety
Validate and submit xEVMPD product records
Perform activities related to SPOR / IDMP
Conduct quality review of ICSRs
Submit relevant documents to the Trial Master File and Pharmacovigilance System Master File
Maintain compliance with SOPs, WIs, global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project plans, and the drug development process
Foster professional working relationships with internal and external project team members
Participate in audits as required
Apply Syneos Health 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 knowledge
Knowledge of medical terminology
Good understanding of Phase II-IV clinical trial processes and/or post-marketing safety requirements
Knowledge of ICH GCP, GVP, and safety and pharmacovigilance regulations
Proficiency in Microsoft Office Suite, Visio, Outlook, Team Share or equivalent workspace tools, and internet
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, high accuracy, and ability to meet deadlines
Understanding of SOPs, work instructions, global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans, and drug development process

Benefits

Comp & perks

Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition
Total rewards program
Total Self culture
Diversity, inclusion, and belonging-focused workplace
Reasonable accommodations for applicants and employees with disabilities
Comprehensive resources including emerging technologies, data, science, and knowledge sharing