Local Case Intake Advisor

Job Title:

Local Case Intake Advisor

Career Level:

C Introduction to role:

Are you ready to make a difference in the world of pharmacovigilance? As a Local Case Intake Advisor, you'll play a crucial role in ensuring the safety of AstraZeneca and Rare Disease Unit products by managing foreign case intake activities for Japan safety reporting. Based in Bangalore, you'll work in the Japan time zone, following the Japanese holiday calendar, and use your Japanese language skills to assess, accept, and accurately enter adverse events.

This position offers the opportunity to work independently, tackle complex problems, and collaborate with internal collaborators to uphold AstraZeneca's high standards for safety and compliance.

• 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.

• 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

• 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…