This role is pivotal for managing Individual Case Safety Reports (ICSRs) ensuring compliance with Japanese regulatory requirements and AstraZeneca's pharmacovigilance standards
Job Summary
This role is pivotal for managing Individual Case Safety Reports (ICSRs) ensuring compliance with Japanese regulatory requirements and AstraZeneca's pharmacovigilance standards.
Candidates will handle personal information and confidential data per regulatory guidelines while performing routine quality checks and manual follow-ups.
The position offers a dynamic environment where contributions lead to significant impacts on patients' lives within a team focused on innovation and collaboration.
Matching Summary
This role is pivotal for managing Individual Case Safety Reports (ICSRs) ensuring compliance with Japanese regulatory requirements and AstraZeneca's pharmacovigilance standards.
Skills & Requirements
Must-have
Japanese language proficiency N2 or higher
Individual Case Safety Reports (ICSR) management
Data entry into safety database systems
Adherence to Japanese regulatory standards
High attention to detail for PII handling
Nice-to-have
Experience with ARGUS safety database
Knowledge of MedDRA and WHO-DD coding
Audit and inspection readiness experience
Cross-functional collaboration skills
Background in pharmacy or medical sciences
Key Requirements
Degree qualified or equivalent experience
1–2 years experience in local data entry
Japanese language proficiency N2 or higher
English language proficiency A2 Waystage based on CEFR