Literature Review Advisor - Global Business Services

Job Title: Literature Review Advisor - Global Business Services

Career Level - C

Introduction to role

The Literature Review Advisor will be an integral part of the local PS team, providing technical and operational support to the Literature Review Team. You will ensure effective delivery to AstraZeneca standards, supporting the local PS organization in achieving compliance with company and regulatory requirements. By building relationships and collaborating with internal and external collaborators, you will ensure local and global PS requirements are met. 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 possess strong analytical skills, a deep understanding of pharmaceutical research methodologies, and literature review processes for drug development, regulatory submissions, and clinical practice.

Accountabilities

What you'll do:

Support provision of the following activities:

• Literature Review Procedures
• Ensure the quality and comprehensiveness of literature searches, including the use of AstraZeneca databases
• Conduct reconciliations ensuring 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, in particular automation and technology changes, to ensure that AZ is leading the way 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 the core components of Good Pharmacovigilance Practice, via contribution to all safety-related processes and brand activities within countries of remit and being audit and inspection ready.
• Support external service providers to meet the company and local regulatory PV requirements.
• Complete all required patient safety trainings in adherence to internal processes and external regulations, and obtain access to relevant systems, such as Safety Database, Regulatory systems, Human Resources systems, Quality Management Systems, and other global or local systems commercial databases as appropriate.
• Maintain current and in-depth knowledge of:
• Global and local procedural and guidance documents
• Marketed status of products in the local country and reference documents (i.e. Core Data Sheet)
• Conditions, obligations, and other commitments relating to product safety or the safe use of AZ products

Essential Skills/Experience

• Pharmacovigilance knowledge excellence
• Good Pharmacovigilance Practice
• Knowledge of health authority’s regulations
• Cross-functional collaborative approach
• Effective and lateral thinking
• Problem-solving
• Vendor management
• Excellent attention to detail
• Excellent written and verbal communication skills

Desirable Skills/Experience

• Influencing and Conflict Resolution skills
• Medical knowledge in company Therapeutic Areas
• Project management
• Successful participation in above-market projects
• Audit & Inspection experience

When we put unexpected teams in the same room, we unleash 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, our work has a direct impact on patients by transforming our ability to develop life-changing medicines. We empower the business to perform at its peak by combining brand new science with leading digital technology platforms and data. Join us at a crucial stage of our journey in becoming a digital and data-led enterprise. Here you can innovate, take ownership, and run with it. You’ll be trusted to explore new solutions in a dynamic environment that offers countless opportunities to learn and grow.

Ready to make a meaningful impact? Apply now!

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 authorisation and employment eligibility verification requirements.