Associate - Local Case Intake Advisor (Japanese Language)
By Admin · Pharmacovigilance & Drug Safety
ROLE OVERVIEW
AstraZeneca, a global leader in biopharmaceuticals, is seeking a dedicated Associate - Local Case Intake Advisor (Japanese Language) to join its Pharmacovigilance team in Bangalore. This critical role sits at the heart of patient safety for AstraZeneca and its Rare Disease Unit products in Japan. By managing Individual Case Safety Reports (ICSRs), you will ensure compliance with stringent Japanese regulatory requirements and uphold AstraZeneca's pharmacovigilance standards. Your bilingual proficiency in English and Japanese will enable seamless case intake, data entry, and collaboration with internal partners. This is a compelling opportunity to contribute directly to the safety profile of life-changing medicines, work in a dynamic GBS PS function, and grow your career in a company that values innovation, collaboration, and patient-centricity. You'll be part of a team that transforms patient safety, with ample opportunities for professional development in a global environment.
ROLE DEFINITION & RESPONSIBILITIES
- •Accept, validate, and perform preliminary assessment of local safety cases from Japan, including conducting phone calls with reporters to gather critical information and clarify case details.
- •Perform accurate data entry into relevant safety database systems for both Japan domestic and foreign cases, ensuring high precision and strict adherence to timelines.
- •Collaborate with internal partners to clarify or triage case information, flag urgent or reportable cases, and resolve blocking issues promptly to maintain compliance.
- •Implement routine quality checks, undertake manual follow-ups, and request follow-up information using specific product/event-related questionnaires.
- •Ensure adherence to Japanese regulatory standards for ICSRs and adverse event reporting, including handling personal and confidential information per regulatory guidelines.
- •Support team in audits and regulatory authority inspections by maintaining audit-ready documentation and implementing corrective and preventative actions for local non-compliance.
- •Perform peer review and contribute to ad-hoc project-specific tasks, including PV aspects related to Organised Data Collection Programmes.
- •Maintain comprehensive knowledge of the Japanese product portfolio and evolving regulation changes to ensure operational excellence and quality management.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Degree qualified in Pharmacy, Medical, or Science, or equivalent experience in a life-sciences field.
- Japanese language proficiency: N2 or higher for listening, writing, and speaking; N3-N1 for reading Japanese Kanji, especially medical terminology.
- English language proficiency at A2 Waystage level based on CEFR.
- 1–2 years of experience in local data entry within a safety database, preferably in pharmacovigilance.
- High attention to detail and ability to identify personal and confidential information (PII) per regulatory guidelines.
- Strong cross-functional collaborative approach and effective lateral thinking for problem-solving.
- Excellent written and verbal communication skills in both Japanese and English.
PREFERRED QUALIFICATIONS
- •Experience in local case intake within Japan
- •Pharmacovigilance knowledge excellence
- •Influencing and conflict resolution skills
- •Project management exposure
- •Experience working with multinational teams
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
APPLICATION ADVISORY
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