Drug Safety Associate

ClinChoice

. Perform Intake/Triage, Data Entry, Quality Review, and Case Finalization/Distribution of safety cases .

Posted 10/31/2026contractRemote • BrazilMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in Intake/Triage, Data Entry, Quality Review, and Case Finalization/Distribution within safety case management, with a strong understanding of regulatory requirements including ICH-GCP and 21 CFR guidelines. Proficient in training and mentoring others in ICSR and safety database processes, particularly using the ARGUS database.

Highest-signal resume keywords

Intake/TriageData EntryQuality ReviewARGUS DatabaseICH-GCP

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data EntryQuality ReviewCase FinalizationFollow-Up QueriesRegulatory RequirementsRare Disease PortfolioSafety Database ProcessesDocumentationMS Office ApplicationsJapanese Language Proficiency

Soft Skills

TrainingMentoring

Tools & Technologies

ARGUS DatabaseMS Office

Industry Keywords

ICH-GCPGVP Modules21 CFR GuidelinesSafety CasesClinical Trials

About the role

Key responsibilities & impact

Perform Intake/Triage, Data Entry, Quality Review, and Case Finalization/Distribution of safety cases
Process cases received from spontaneous, literature, regulatory authority, solicited, and clinical trial sources
Raise follow-up queries as necessary and document them in the safety database
Use the ARGUS database for case processing
Handle rare disease portfolio activities
Apply ICH-GCP, relevant GVP modules, 21 CFR guidelines, and other regulatory requirements
Train and mentor others on ICSR and safety database processes

Requirements

What you’ll need

Bachelor’s or Master’s in Pharmacy / Life Sciences or above and in alignment with project / business team requirements
Minimum of 3 to 5 years of relevant experience in the identified functional domain/business workstream
Hands-on experience with MS Office applications (Outlook, Excel, Word, PowerPoint, etc.)
Must be able to write and speak Japanese
Experience in Intake/Triage, Data Entry, Quality Review, Case Finalization/Distribution of cases received from Spontaneous, Literature, Regulatory Authority, Solicited and Clinical trials
Experience in raising follow-up queries, as necessary, with appropriate documentation in the safety database
Experience in ARGUS database
Experience in rare disease portfolio
Thorough knowledge of ICH-GCP, relevant GVP module, 21 CFR guidelines and other regulatory requirements
Training and mentoring skill (ICSR, Safety database, etc.)

Benefits

Comp & perks

Remote work arrangement
Dynamic working hours