About the role

Aplyr's Quick Take

This role is for a Drug Safety Associate Consultant focusing on case processing and pharmacovigilance. You'll handle data entry, quality review, and case finalization for safety reports, primarily using the ARGUS database. It's an individual contributor position requiring specialized knowledge in regulatory guidelines and experience in rare diseases.

Good fit

Ideal candidates have 3-5 years of experience in drug safety or pharmacovigilance, particularly with ICH-GCP and regulatory compliance. Strong communication skills in Japanese and a background in life sciences are essential.

Worth noting

The role is remote but requires dynamic working hours, which may not suit everyone. Additionally, the requirement for Japanese language skills is quite specific and could limit the candidate pool.

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.

Skills & Tags

gcp ai data product

Aplyr's read

ClinChoice is a dynamic global CRO catering to the pharmaceutical and biotech sectors, attracting professionals skilled in regulatory affairs, biostatistics, and clinical programming.
Synthesized from recent postings & public sources

What's promising

•ClinChoice offers a diverse range of roles in clinical research, appealing to specialists in biostatistics and regulatory affairs.
•The company provides opportunities for remote and hybrid work, offering flexibility to its workforce.
•ClinChoice's global presence allows employees to engage with international projects and clients.

What to watch

•Limited public information about ClinChoice's workplace culture and employee satisfaction.
•The company may face competition from larger CROs with more established reputations.
•Potential candidates might find limited career advancement information publicly available.

Why ClinChoice

•ClinChoice focuses on comprehensive services across pharmaceuticals, biotechnology, and medical devices.
•The company has a strong emphasis on statistical programming and regulatory affairs roles.
•ClinChoice's recent hiring trends show a commitment to remote and hybrid work models.

Aplyr’s read is generated by AI from public sources. Was it useful?

About ClinChoice

ClinChoice

clinchoice.com

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ClinChoice is a global clinical research organization (CRO) that provides comprehensive services to the pharmaceutical, biotechnology, and medical device industries.