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.

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

When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

AstraZeneca offers an environment where you can truly make an impact. Our distributed team is dedicated to unlocking the power of science to improve patients' lives. With a focus on innovation and collaboration, we provide opportunities for growth and development while working on exciting projects that inspire change. Our ambitious spirit encourages creativity and smart risk-taking, allowing you to turn ideas into reality. Join us to be part of a dynamic team that supports each other while pushing boundaries.

Ready to take on this exciting challenge? Apply now to become a Local Case Intake Advisor at AstraZeneca!

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.