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ClinChoice

Drug Safety Associate Consultant - Remote

1w

ClinChoice

BR · Contract · BRL 120,000 – BRL 200,000

About this role

ClinChoice partners with the world's largest pharmaceutical and medical device innovators. We deliver pharmacovigilance expertise to advance healthcare, accelerate clinical trials, and enhance patient safety through data-driven insights and real-world analysis. Our global network includes centers in the United States, Mexico, UK, Armenia, China, Japan, India, and Philippines.

As a Drug Safety Associate Consultant, perform case processing including intake, triage, data entry, quality review, and finalization for cases from spontaneous reports, literature, regulatory authorities, solicited sources, and clinical trials. Raise follow-up queries with proper documentation in the safety database. Utilize ARGUS database and manage rare disease portfolio.

Join a team focused on regulatory compliance locally and globally. Work remotely from Brazil with dynamic hours, supporting partners in clinical operations, biometrics, regulatory affairs, and toxicology. Collaborate via cutting-edge solutions from industry and technology partnerships.

Gain opportunities to apply ICH-GCP, GVP modules, and 21 CFR guidelines in daily operations. Develop training and mentoring skills in ICSR and safety databases. Contribute to future-defining advancements in pharmacovigilance.

Requirements

  • Bachelor’s or Master’s in Pharmacy / Life Sciences or above
  • Minimum of 3 to 5 years of relevant experience in pharmacovigilance case processing
  • Hands-on experience with MS Office applications including Outlook, Excel, Word, PowerPoint
  • Experience in ARGUS database
  • Experience in rare disease portfolio
  • Thorough knowledge of ICH-GCP, relevant GVP module, 21 CFR guidelines and other regulatory requirements
  • Ability to write and speak Japanese

Responsibilities

  • Perform intake/triage, data entry, quality review, case finalization and distribution for cases from spontaneous, literature, regulatory authority, solicited and clinical trials sources
  • Raise follow-up queries as necessary with appropriate documentation in the safety database
  • Utilize ARGUS database for case processing
  • Manage rare disease portfolio cases
  • Apply thorough knowledge of ICH-GCP, relevant GVP modules, 21 CFR guidelines and other regulatory requirements
  • Provide training and mentoring on ICSR and safety database operations

Benefits

  • Remote work from Brazil
  • Dynamic working hours
  • Global delivery network support