Pharmacy Jobs: AstraZeneca is Hiring for the role of Local Case Intake Advisor| Apply Now for AstraZeneca Career
Are you interested in pharmacovigilance job role and looking for Pharmacy jobs? AstraZeneca is inviting applications for the role of Local Case Intake Advisor in Bengaluru, Karnataka, India. This exciting opportunity allows professionals in pharmacovigilance to play a crucial part in ensuring the safety of AstraZeneca and Rare Disease Unit products. The position focuses on managing foreign case intake activities for Japan safety reporting, requiring strong Japanese language proficiency and a keen eye for detail. Join AstraZeneca Career team and contribute to life-changing science while advancing your career in global safety and compliance.
Job Details:
- Job Title: Local Case Intake Advisor
- Location: Bengaluru, Karnataka, India
- Job ID: R-235804
About the Company:
AstraZeneca is a leading global, science-led biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that transform lives. With a strong focus on oncology, cardiovascular, renal, metabolism, and rare diseases, AstraZeneca operates in over 100 countries and its medicines are used by millions of patients worldwide.
The company’s culture is driven by a passion for innovation, collaboration, and patient-centric research. AstraZeneca’s global teams work together to accelerate the delivery of life-changing therapies while upholding the highest standards of ethics and scientific excellence. In India, AstraZeneca continues to build its legacy of scientific advancement by providing a dynamic environment where professionals can grow, contribute, and make a real impact in the healthcare industry. Through AstraZeneca Career portal, the young professionals are gaining opportunities in Pharmacy Jobs in various sectors including pharmacovigilance job role, regulatory affairs and related areas.
Education:
Graduation in Pharmacy
Key Responsibilities:
- 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)
- Perform other related duties as assigned or requested per business needs.
Essential Skills/Experience:
- 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 Required for this Pharmacovigilance Job Role :
- 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
