Assistant Manager – Pharmacovigilance Local Case Intake (Japanese Language)
By Admin · Pharmacovigilance & Drug Safety
ROLE OVERVIEW
AstraZeneca's Local Case Intake function is the front door of the company's patient-safety ecosystem, and this Assistant Manager role owns it for the Japanese market. Leading a team of Local Case Intake Advisors, you will make sure every adverse event report originating from Japanese Marketing Companies is captured, triaged, followed up and submitted within regulatory clocks. Because Japan is one of AstraZeneca's largest and most tightly regulated commercial markets, accuracy here directly protects licence continuity, Health Authority credibility and patient trust. This is a compelling next step for a pharmacovigilance professional with Japanese language capability who wants to move from individual case processing into people leadership, gaining structured exposure to PMDA interactions, Pharmacovigilance System Master File governance, inspection readiness and global safety transformation work inside a digitally enabled organisation.
ROLE DEFINITION & RESPONSIBILITIES
- •Lead, coach and develop a team of Local Case Intake Advisors, setting daily priorities, balancing workload and driving consistent quality and throughput.
- •Oversee end-to-end intake, triage, data entry, follow-up and submission of Japanese-market ICSRs within regulatory and company timelines.
- •Translate and quality-review Japanese source documents from spontaneous, solicited and literature sources to ensure accurate medical coding.
- •Act as a point of contact for Health Authority queries, coordinating timely, compliant responses with global safety and regulatory partners.
- •Perform quality checks, own corrective and preventive action plans and maintain continuous audit and inspection readiness.
- •Track operational metrics and produce benchmark reports that drive cycle-time, efficiency and data-quality improvements.
- •Maintain Pharmacovigilance System Master File contributions and local SOPs, ensuring the team completes all required training.
- •Build cross-functional relationships with Medical Affairs, Regulatory, Quality and Commercial teams, and plan after-hours coverage so adverse events are handled without interruption.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Degree in Pharmacy, Medicine, Life Sciences or a related scientific discipline (B.Pharm, M.Pharm, PharmD, MBBS, BSc/MSc).
- Five to eight years of pharmacovigilance experience in a pharmaceutical company, CRO or global capability centre, including ICSR case intake and processing.
- Business-level Japanese language proficiency (JLPT N2/N1 or equivalent) alongside strong written and verbal English.
- Working knowledge of global and Japanese PV regulations, including ICH E2B/E2D, GVP and PMDA requirements.
- Prior experience leading, mentoring or supervising a case intake or case processing team in a fast-paced environment.
- Hands-on familiarity with safety databases such as Argus or ARISg.
- Demonstrated experience supporting audits and inspections with a track record of inspection readiness.
PREFERRED QUALIFICATIONS
- •Contributions to the Pharmacovigilance System Master File (PSMF)
- •Familiarity with Risk Management Plans (RMPs) and literature surveillance for adverse events
- •Lean, Six Sigma or continuous-improvement certification
- •Experience designing after-hours or business-continuity AE intake models
- •Exposure to global safety system migrations and change programmes
REQUIRED VERIFIED SKILLS
COMPENSATION & REWARDS
ORGANIZATION CONTEXT & CULTURE
AstraZeneca is a global, science-led biopharmaceutical company focused on the discovery, development, and commercialisation of prescription medicines. The company operates in various therapeutic areas, including Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. AstraZeneca is committed to pushing the boundaries of science to deliver life-changing medicines and improve patient outcomes worldwide.
EXPECTED CAREER ROADMAP
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