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Literature Review 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: Literature Review Advisor - Global Business Services

Location: [Insert Location Here]

Career Level: C

Introduction to Role: The Literature Review Advisor will be an integral part of the local Patient Safety (PS) team, providing technical and operational support to the Literature Review Team. You will be responsible for ensuring the effective delivery of AstraZeneca standards and supporting the local PS organization in achieving compliance with company and regulatory requirements. This role involves managing comprehensive literature reviews within the pharmaceutical sector, ensuring the quality, accuracy, and relevance of all published material. The ideal candidate will have strong analytical skills, a deep understanding of pharmaceutical research methodologies, and experience in literature review processes for drug development, regulatory submissions, and clinical practice.

Accountabilities:

Literature Review Procedures:

  • Ensure the quality and comprehensiveness of literature searches, including the use of AstraZeneca databases.

  • Conduct reconciliations to ensure the accuracy of pharmacovigilance data that is transferred and received.

  • Oversee the identification, collection, and analysis of relevant scientific publications, clinical studies, and regulatory reports.

  • Keep up to date with industry developments, particularly automation and technological changes, to ensure AstraZeneca remains a leader in conducting literature searches.

Collaboration & Cross-Functional Support:

  • Collaborate with cross-functional teams (Marketing Company stakeholders, R&D, regulatory, medical affairs, clinical operations) to provide literature-based insights that inform drug development and regulatory strategies.

  • Work closely with subject matter experts to develop clear, concise, and scientifically sound literature materials, summaries, and reports.

  • Collaborate with external collaborators and/or academic institutions on literature review-related tasks.

Regulatory & Compliance Adherence:

  • Actively contribute to maintaining Good Pharmacovigilance Practices by supporting safety-related processes and brand activities, ensuring audit readiness.

  • Support external service providers in meeting company and local regulatory pharmacovigilance requirements.

  • Complete all required patient safety training, adhere to internal processes and external regulations, and obtain access to relevant systems (e.g., Safety Database, Regulatory systems, Human Resources systems, Quality Management Systems).

  • Maintain in-depth knowledge of global and local procedural and guidance documents, marketed product status, and commitments related to product safety.

Essential Skills/Experience:

  • Expertise in Pharmacovigilance and Good Pharmacovigilance Practices.

  • Knowledge of health authority regulations.

  • Strong cross-functional collaboration skills.

  • Ability to think laterally and solve problems effectively.

  • Vendor management experience.

  • Excellent attention to detail and communication skills (both written and verbal).

Desirable Skills/Experience:

  • Influencing and Conflict Resolution skills.

  • Medical knowledge in company therapeutic areas.

  • Project management experience.

  • Participation 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 is committed to building an inclusive and diverse team, representing all backgrounds and perspectives. Our work directly impacts patients by transforming our ability to develop life-changing medicines, powered by cutting-edge science and digital technologies. Join us in becoming a digital and data-led enterprise, where you can innovate, take ownership, and explore new solutions in a dynamic environment that promotes continuous learning and growth.

Ready to make a meaningful impact? Apply now!