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Drug Safety Associate Consultant
Contract type
One-time
Work mode
Remote · Brazil
Experience
Mid-level · 3+ years
Job description
Contract role in pharmacovigilance case processing, handling intake, triage, data entry, quality review and finalization/distribution of safety cases in ARGUS. Based in Brazil, working remotely.
At a glance
- Employment
- Contract
- Work mode
- Remote · Brazil
- Languages
- Japanese
What you'll do
- Intake/Triage, Data Entry, Quality Review, Case Finalization/Distribution of cases received from sources such as Spontaneous, Literature, Regulatory Authority, Solicited and Clinical trials
- Raise follow-up queries, as necessary, with appropriate documentation in the safety database
- Work with the ARGUS database
- Work on a rare disease portfolio
- Train and mentor on ICSR, safety database etc.
What we're looking for
- 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 identified functional domain/ business workstream
- Experience in ARGUS database
- Experience in rare disease portfolio
- Thorough knowledge of ICH-GCP, relevant GVP module, 21 CFR guidelines and other regulatory requirements
- Hands-on experience with MS Office applications (Outlook, Excel, Word, Power Point etc.)
- Must be able to write and speak Japanese
- Dynamic working hours
Apply
About ClinChoice
ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis.
Key facts
- 1995
- Established in 1995
- Provides expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology
- Forged partnerships with industry bodies and technology companies