Drug Safety Associate

This is a fully remote position, open to applicants in Brazil.

📋 Description

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

• Manage cases obtained from spontaneous reports, literature, regulatory authorities, solicited sources, and clinical trials.

• Initiate follow-up inquiries as required and document them within the safety database.

• Utilize the ARGUS database for efficient case processing.

• Oversee activities related to the rare disease portfolio.

• Implement ICH-GCP, relevant GVP modules, 21 CFR guidelines, and other regulatory standards.

• Provide training and mentorship to others on ICSR and safety database procedures.

⛳️ Requirements

• Bachelor’s or Master’s degree in Pharmacy / Life Sciences or a related field, aligning with project/business team needs.

• At least 3 to 5 years of pertinent experience in the specified functional domain/business workstream.

• Proficient in MS Office applications (Outlook, Excel, Word, PowerPoint, etc.).

• Proficiency in written and spoken Japanese is required.

• Experience in Intake/Triage, Data Entry, Quality Review, and Case Finalization/Distribution for cases from spontaneous reports, literature, regulatory authorities, solicited sources, and clinical trials.

• Demonstrated ability to raise follow-up queries as necessary, with proper documentation in the safety database.

• Familiarity with the ARGUS database.

• Experience with rare disease portfolio management.

• In-depth understanding of ICH-GCP, relevant GVP modules, 21 CFR guidelines, and other regulatory requirements.

• Skills in training and mentoring (ICSR, safety database, etc.).

🏝️ Benefits

• Flexible remote work arrangement.

• Dynamic working hours.