Drug Safety Associate

Job not on LinkedIn

🔥 9 minutes ago

🇧🇷 Brazil – Remote

⏳ Contract/Temporary

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 10%

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ClinChoice

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1998

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ClinChoice is a global full-service contract research organization (CRO) established in 1995, specializing in clinical development, post-marketing, and functional service support for the pharmaceutical, biotechnology, and medical devices industries. They provide comprehensive solutions from early clinical development to post-approval lifecycle management, with expertise in a variety of therapeutic areas such as autoimmune and inflammation, dermatology, endocrinology, infectious diseases, neuroscience, and oncology. ClinChoice aims to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. The company supports its clients with clinical, regulatory, and operational expertise across all phases of product development.

📋 Description

• 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

• 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

• Remote work arrangement • Dynamic working hours

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