Case Processing Specialist Consultant

buscojobs Brasil; Amazonas; A distancia; PEN 35,000 - 50,000; Jornada completa

Descripción de la vacante

A leading clinical operations firm seeks a Senior Executive / Specialist for case processing, offering the opportunity to work remotely. Ideal candidates will possess a strong background in pharmacy or life sciences, with 3 to 5 years in case processing. Proficiency in Japanese and familiarity with ARGUS database are essential. This role involves quality review, data entry, and training, aimed at maintaining regulatory compliance in healthcare.

Formación

• 3 to 5 years of relevant experience in case processing or related domain.
• Thorough knowledge of ICH-GCP and regulatory requirements.
• Experience in raising follow-up queries with documentation.

Responsabilidades

• Manage data entry and quality review in the safety database.
• Finalize cases and distribute them based on various sources.
• Train and mentor new hires in safety regulations.

Conocimientos

Data Entry

Quality Review

Japanese language proficiency

Training and mentoring

Educación

Bachelor’s or Master’s in Pharmacy / Life Sciences

Herramientas

ARGUS database

MS Office applications

Descripción del empleo

Overview

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.