job title: Local case intake advisor(astrazeneca)

Roles and Responsibilities

Accountabilities:

• Accept, validate, and process safety cases for Foreign case intake activities (both AstraZeneca and RDU products)

• Perform all required data entry into relevant safety database systems (e.g., ARGUS) with high accuracy and attention to compliance

• Implement Corrective and Preventative Actions in the event of local non-compliance and process completed late logs when required

• Perform reconciliations ensuring the accuracy of pharmacovigilance data that is transferred and received

• Undertake manual follow-up where required disseminating clear and accurate information

• Identify and resolve discrepancies, initiate clarification requests where appropriate

• Communicate with internal collaborators to resolve data entry issues or clarify case content as needed

• Escalate any urgent or high-risk cases, following established procedures

• Adhere to internal standard for data entry into relevant safety database (Global Safety database), in accordance with the relevant global / Japan regulations and procedural guidance

• Collaborate with internal collaborators (e.g., Medical Information, Regulatory Affairs, Quality) to clarify, complete, or triage case information

• Follow SOPs for filing and archiving safety documentation to achieve audit readiness

• Support responses to Health Authority (PMDA) queries on intake cases as required

• Support team in relation to audits or regulatory authority inspections

• Complete all required training and maintain up-to-date expertise on applicable regulations and procedures

• Maintain knowledge of Japanese product portfolio and regulation changes relevant to safety reporting, including Japan regulatory authority regulations, global and Japan procedural and guidance documents

• Contribute to effective operational implementation of the Quality Management System appropriate to the GvP field

• Perform Peer review and any ad-hoc project specific tasks and activities as assigned

• Perform literature search and related activities for AZ product portfolio if required

• Review, assess and process safety data and information received from various sources; distribute reports and/or metrics onwards to both internal and external third parties following applicable regulations and standard operating procedures (SOPs), under guidance and support of the appropriate Local Case Intake Team Managers and/or senior team members

• Perform other related duties as assigned or requested per business needs.

Essential Skills/Experience:

• Degree Qualified

• Japanese language proficiency Test (JLPT): N3 or higher (note: N3 level not necessarily required if the applicant has 1-2 years of experience in data entry to Global Safety Database)

• English language proficiency in listening, writing and reading: A2 Waystage based on Common European Framework Reference for Languages (CEFR)

• Life-science background

• 1–2 years of experience in clinical trial case handling

• Cross functional collaborative approach

• Effective and lateral thinking

• Problem solving

• Excellent written and verbal communication skills

Desirable Skills/Experience:

• Degree Qualified – Pharmacy / Medical / Science

• Pharmacovigilance knowledge excellence

• 1–2 years of experience in data entry, preferably within a safety database

• Experience in local case intake

• Experience with ARGUS

• Familiarity with Good Pharmacovigilance Practice / Good Clinical Practice and relevant regulations including Health Authority regulations)

• Basic knowledge of standard office software packages (Word, Excel)

• Experience working with multinational teams

• Ability to quickly develop good understanding of AE and drug coding conventions (MedDRA, WHO-DD)

• Successful participation in above-market projects

• Audit & Inspection experience