Patient Safety Compliance

Patient Safety Compliance

AstraZeneca have an opportunity within the Patient Safety Compliance team based in Alderley Park, on a contract basis.

The position involves:

- Providing compliance support/information to Patient Safety leadership and other internal teams
- maintaining global compliance systems
- Monitor compliance with global and local regulatory and performance timelines and procedures
- To monitor process metrics and publish and share data
- To call out deviations in performance and compliance data and ensure appropriate CAPAs
- To challenge the status quo to identify improvement opportunities
- Coordinate global data regarding reasons for late reporting and corrective actions to prevent future late reporting from clinical, regulatory and marketing for inclusion in safety reports to regulatory authorities and per internal timelines
- Support regulatory inspections and internal audits
- Review safety data output and produce monthly/quarterly summaries as well as data for PV Master file
- Creates material and provides training support for compliance
- Have effective project-management skills, including the ability to manage multiple competing tasks and people
- Participates in cross-functional project team meetings to provide information regarding compliance issues/findings and solutions
- Ability to run BO reports from safety database and understand data
- General understanding of Serious Adverse Event case handling

The successful candidate will have:

- A degree or equivalent in Biomedical Science or a related subject
- Proven Patient safety/pharmacovigilance experience
- Detail oriented
- Analytical
- Good communicator
- Ability to work independently
- Ability to multi task

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