Local Case Intake Advisor

Job Title: Local Case Intake Advisor

GCL: C

Introduction to role:

Are you ready to make a difference in the world of pharmacovigilance? As a Case Intake Advisor, you'll play a crucial role in ensuring the safety of AstraZeneca and Rare Disease Unit products in Japan. Based in Bangalore, you'll be responsible for assessing, accepting, and accurately entering adverse events, including those from clinical trials. Your expertise will help maintain compliance with national and AstraZeneca safety standards. Fluent in Japanese or with experience in PV data entry, you'll work in the Japan time zone and follow the Japanese holiday calendar. Join us and chip in to life-changing medicines!

Accountabilities:

• Accept, validate, and process safety cases for local case data entry relevant 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

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

• If required, undertake manual follow-up disseminating clear and accurate information

• Request follow-up information for the completion of case reports making use of specific product/event-related questionnaires when vital

• Identify and resolve discrepancies; initiate clarification requests where appropriate

• Conduct in-line QC for clinical trial safety cases, ensuring compliance with internal SOPs and regulatory requirements

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

• Call out 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; refer to Key Relationships) 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

• Chip in to effective operational implementation of the Quality Management System appropriate to the GvP rigor

• Per process/project needs, perform Peer review and any ad-hoc project specific tasks and activities as assigned

• If required, 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): N2 or higher (N3 possible with confirmed 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 familiarity with local data entry in a safety database

• High attention to detail and ability to identify personal/confidential information (PII)

• 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

• Experience with ARGUS

• Experience in local case intake

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

• Influencing, and Conflict Resolution skills

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

• Experience working with multinational teams

• Medical knowledge in company Therapeutic Areas

• Project management

• 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.

At AstraZeneca, you'll be part of a dedicated distributed team that powers our rapidly growing enterprise. We demonstrate exciting new technology and digital innovations to accelerate our evolution, ultimately impacting patients' lives. With an ambitious spirit, we apply creativity to every task, taking smart risks to turn ideas into reality. Our dynamic environment develops collaboration among bright minds who support each other while pushing boundaries. Here, you'll find countless opportunities to build an outstanding reputation while being rewarded for your successes.

Ready to make an impact? Apply now to join our team!

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.