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Local Case Intake Advisor - Global Business Services

2+ years
Not Disclosed
10 April 23, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Local Case Intake Advisor (Korean Language) - Global Business Services

Location: [Insert Location Here]

Career Level: C

Introduction to Role: As a Local Case Intake Advisor, you will be responsible for managing the intake, processing, and reporting of Individual Case Safety Reports (ICSRs) at the local level. You will collaborate with specific local Marketing Companies to ensure compliance with AstraZeneca (AZ) and relevant national regulatory requirements. Serving as the primary liaison between those Marketing Companies and GBS-PS, you will work under the guidance of Case Intake Team Managers to deliver routine activities independently, resolve moderate scope problems, and ensure all activities align with company values and compliance standards.

Accountabilities:

Pharmacovigilance Support:

  • Support local processes, procedures, and systems for the collection, reporting, and tracking of Adverse Events (AEs).

  • Review, assess, and process safety data from various sources and distribute reports to internal and external third parties.

  • Identify and collect information on Product Quality Complaints (PQC) and Product Security complaints for AE reporting.

Regulatory Authority Support:

  • Provide prompt assistance for regulatory authority queries related to the Patient Safety function.

  • Implement Corrective and Preventative Actions (CAPA) in the event of local non-compliance.

  • Conduct periodic screenings of regulatory authority databases for adverse events.

Documentation and Reporting:

  • Maintain filing and archiving practices for patient safety documents.

  • Ensure accurate reconciliations of pharmacovigilance data transferred and received.

  • Perform literature searches for the MC product portfolio when required.

Safety Reporting and Follow-Up:

  • Undertake manual follow-ups and provide accurate information based on approved call scripts.

  • Assist in audits and regulatory inspections related to pharmacovigilance activities.

Training and Compliance:

  • Complete all required patient safety training and maintain access to relevant systems.

  • Actively contribute to maintaining Good Pharmacovigilance Practices and being audit-ready.

  • Ensure the team adheres to company and local regulatory requirements in collaboration with external service providers.

Essential Skills/Experience:

  • Degree in Pharmacy, Medical, or Science.

  • Fluency in Korean.

  • In-depth knowledge of Pharmacovigilance and Good Pharmacovigilance Practices.

  • Knowledge of health authority regulations.

  • Strong cross-functional collaboration skills.

  • Problem-solving and lateral thinking abilities.

  • Attention to detail with excellent written and verbal communication skills.

Desirable Skills/Experience:

  • Skills in Influencing and Conflict Resolution.

  • Medical knowledge in the company's Therapeutic Areas.

  • Project management experience.

  • Experience in above-market projects.

  • Audit & Inspection experience.

Work Model:

  • Minimum of three days per week in-office, with flexibility to accommodate individual needs.

About AstraZeneca: AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team, representing all backgrounds, perspectives, and skills. Our work directly impacts patients, and we are at the forefront of transforming our ability to develop life-changing medicines by combining cutting-edge science with digital technology platforms and data. Join us in becoming a digital and data-led enterprise and contribute to innovation, ownership, and new solutions in a dynamic environment that encourages lifelong learning.

Ready to make a difference? Apply now to join our team!