Regulatory Review Advisor, Patient Safety

Job Title: Regulatory Review Advisor Patient Safety

GCL : C2

Introduction to role:

Are you ready to elevate regulatory reporting standards that protect patients and enable faster delivery of therapies As a Regulatory Review Advisor Patient Safety you will be the trusted guardian of our safety reporting ensuring that every submission to health authorities is precise timely and audit-ready.

You will join a fast paced connected team that turns sophisticated pharmacovigilance requirements into clear repeatable processes. Your work will reduce risk prevent delays and strengthen trust with regulators worldwide. Can you picture yourself translating evolving global guidance into practical direction for cross-functional teams while building robust inspection-ready documentation

Accountabilities:

Regulatory Reporting Compliance: Ensure timely and accurate submission of Adverse Event Reports Periodic Safety Update Reports and other required documentation; interpret and apply global regulatory reporting requirements; monitor guideline updates and align internal GBS processes with evolving reporting standards.

Adverse Event and Safety Reporting: Lead all aspects of pharmacovigilance reporting activities in compliance with Good Pharmacovigilance Practices; work closely with safety teams to assess process and submit Individual Case Safety Reports within required timescales; assist in detection and risk assessment activities to client safety protocols.

Prepare review and submit regulatory reports accurately and completely. Follow all legal standards. Keep documentation ready for audits and inspections. Collaborate with Quality Assurance Medical Affairs and Client Patient Safety Teams to align on reporting needs.

Training and Process Improvement: Provide training and guidance to GBS internal teams on regulatory reporting obligations and best practices; support audits and inspections by regulatory authorities and implement corrective actions as needed.

Operational Perfection and Readiness: Actively chip in to maintaining the core components of Good Pharmacovigilance Practice across safety-related processes and brand activities within countries of remit; support external service providers to meet company and local regulatory PV requirements; complete all required patient safety trainings and secure access to relevant systems (Safety Database Regulatory systems HR systems Quality Management Systems and other global or local systems and commercial databases as appropriate); maintain current in-depth knowledge of relevant country regulations global and local procedural and guidance documents and conditions obligations and other commitments relating to product safety or the safe use of AZ products.

Essential Skills/Experience:

• Ensure timely and accurate submission of regulatory reports including Adverse Event Reports Periodic Safety Update Reports and other required documentation.
• Interpret and apply global regulatory reporting requirements including those for health authorities.
• Monitor updates to regulatory guidelines and ensure internal GBS processes align with evolving reporting standards.
• Coordinate pharmacovigilance reporting activities ensuring compliance with Good Pharmacovigilance Practices.
• Work closely with safety teams to assess process and submit Individual Case Safety Reports within required timescales.
• Assist in detection and risk assessment activities to client safety protocols.
• Prepare review and submit regulatory reports ensuring completeness accuracy and compliance within legal requirements.
• Maintain documentation for regulatory audits and inspections.
• Collaborate with teams (e.g. Quality Assurance Medical Affairs Client PS Teams) to ensure alignment on regulatory reporting requirements.
• Provide training and mentorship to GBS internal teams on regulatory reporting obligations and standard methodologies.
• Support audits and inspections by regulatory authorities and implement corrective actions as needed.
• Actively chip in 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.
• Support outside vendors to meet the company and local regulatory PV requirements.
• Complete all required patient safety trainings in adherence to internal processes and external regulations and acquire 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 and knowledge of:

• Relevant country regulatory authority regulations

• Global and local and guidance documents

• Conditions obligations and commitments relating to product safety or the safe use of AZ products

Desirable Skills/Experience:

• Experience with safety databases and regulatory systems (e.g. Argus/ArisGlobal E2B submissions EudraVigilance).
• Familiarity with MedDRA and WHODrug coding case processing workflows and data quality controls.
• Track record of leading or supporting regulatory audits and inspections including corrective and preventive action planning.
• Process improvement attitude with experience standardizing procedures or implementing automation to improve reporting reliability and speed.
• Tight-knit collaboration skills across Quality Medical Affairs and external service providers with the ability to turn changing regulations into clear guidance.

When we put unexpected teams in the same room we fuel ambitious thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge

perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca:

Here your expertise powers an enterprise driven by science and purpose where every accurate report and informed decision can help bring therapies to patients faster. You will partner across a global network that thrives on curiosity and honest feedback combining smart automation data insights and practical rigor to solve real problems in real time. We value kindness alongside ambition invest in learning at pace and bring diverse perspectives together to challenge how its always been doneso your contribution adds up to safer medicines and a wider impact on society and the planet.

Call to Action:

Ready to shape regulatory excellence that protects patients and accelerates progressstep forward and make your impact today!

Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.