Case Processing Specialist Consultant

buscojobs Brasil; Rio de Janeiro; Teletrabalho; BRL 20.000 - 80.000; Tempo integral

Resumo da oferta

A global healthcare partner is seeking a Senior Executive / Specialist in Case Processing. This remote role requires expertise in case management and regulatory compliance, with a focus on rare diseases. Candidates should have strong experience with the ARGUS database and proficiency in Japanese. A Bachelor’s or Master’s degree in relevant fields is mandatory, along with 3 to 5 years of relevant experience. Competitive candidate will demonstrate skills in training and mentoring while handling dynamic workloads.

Qualificações

• Minimum of 3 to 5 years of relevant experience in identified functional domain.
• Must possess thorough knowledge of regulatory requirements.
• Dynamic working hours.

Responsabilidades

• Experience in raising follow-up queries with documentation.
• Experience in case processing and distribution.
• Experience in rare disease portfolio.

Conhecimentos

Intake / Triage

Data Entry

Quality Review

Case Finalization

Knowledge of ICH-GCP

Training and mentoring

MS Office applications

Japanese proficiency

Formação académica

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

Ferramentas

ARGUS database

Descrição da oferta de emprego

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.