Patient Safety Senior Specialist

**JOB TITLE**

**Patient Safety Senior Specialist**

**ABOUT ASTRAZENECA**

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

**ROLE SUMMARY**
- At AstraZeneca, our values-based culture contributes to a desirable working environment, a purposeful mission of putting patients first who benefit from following the science, doing the right thing, and a confident entrepreneurial spirit.
- we are dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to patients and society. An inclusive culture that champions diversity and collaboration, and is always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare.

**What you’ll do**
- Responsible for monitoring and supporting the day-to-day PS activities in KSA.
- Review and update, the local PS procedural documents in KSA.
- Review and Update the local PSMF that covers the local health authority's requirements
- Ensure local information relating to pharmacovigilance activities is reflected correctly in the Pharmacovigilance System Master File (PSMF)
- Support & monitor the implementation of patient safety activities in KSA & provide regular patient safety support to the local distributors/vendors to meet the local health authority requirements.
- Maintaining an in-depth knowledge of the local health authority regulations and updating regional lead and local teams with any recent changes in legislation/guidance for discussion and escalation to relevant stakeholders in global Patient Safety as required.
- Oversee & monitor all safety-related processes, issues, and brand activities in KSA including product risk management plans and associated activities.
- Support the creation, implementation, and maintenance of local risk management plans and risk minimization activities to support regulatory submissions in collaboration with cross-functional teams.
- Manage different PS systems (Argus, Orbit, My time and VQV, Nominated Signatory Portal, ERV, Veeva and ECMS).
- Support local safety management agreements and clinical study protocols to fulfill AstraZeneca and local regulatory safety reporting requirements.
- Support AstraZeneca’s external patient safety service provider to meet AstraZeneca and local regulatory pharmacovigilance requirements.
- Ensure cross-function collaboration through sharing patient safety knowledge with the local MC teams (e.g., Marketing, Sales, Regulatory Affairs, Medical Affairs)
- Support the implementation of all elements of Quality management systems related to patient safety (Change Management, Continuous Improvement plan, Issues, Root Cause Analysis, CAPAs, Risks, Self-assessment, Management review meetings, Vendor quality review, PS Agreements, Training & etc.)
- Monitor and support Patient safety activities related to the processing and handling of Individual Case Safety Reports (ICSRs), and follow-up cases, received from clinical and post-marketed sources for AstraZeneca & RDU products.
- Ensure timely submission of ICSR, follow-up cases, and other safety documents (PBRERs, DSURs, Signals, SUSARs, RMPs, DHPCs, etc) to local health authorities.
- Support the annual update and testing of the local Business Continuity Process (BCP)
- Support delivery of PS training to local AstraZeneca staff and locally engaged vendors including annual refresher training
- Support the Management of the local Health Authority interactions and queries, such as for ICSR-related products, related safety concerns, and educational materials associated with the Risk Management Plan (RMP)
- Ensures corrective and preventative actions are taken in the event of local non-compliance.
- Support review of medical and scientific literature to identify possible Adverse events in accordance with AstraZeneca and local regulatory pharmacovigilance requirements.
- Management of the PV aspects relating to Organized Data Collection Programmes, Digital and Social Media activities, and other arrangements with external parties (such as Externally Sponsored Research (ESR), health authorities’ partnerships, or other collaborations).
- Support patient safety projects at local & global levels.
- Act as PS mentor to support newly appointed patient safety staff in AstraZeneca / External vendor.
- Support management of local safety agreements and update Pharmacovigilance Agreement Listings.
- Review & lead the submission of the annual patient safety checklist.
- Ensure an after-hours process is in place, to ensure a customer can report an AE and respond to regulatory authority questions.
- Supports filing and archiving practices of patient safety documents.