Drug Safety Associate Consultant
1 semana atrás
Job Description
Job Title: Senior Executive / Specialist - Case Processing
Employment Type: Contract
Location: Brazil (Remote)
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.
Our global delivery network has expanded to centers and satellite offices in the United States, Mexico, United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally.
We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision.
Primary Responsibilities:
- Experience in Intake/Triage, Data Entry, Quality Review, Case Finalization/Distribution of cases received from sources such as 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.
- Must possess thorough knowledge of ICH-GCP, relevant GVP module, 21 CFR guidelines and other regulatory requirements.
- Training and mentoring skill (ICSR, Safety database etc.).
Candidate Profile:
- 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.
- Must have hands on experience with MS office applications (Outlook, Excel, Word, Power Point etc.).
- Must be able to Write and speak Japanese.
- Dynamic working hours.
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