Regulatory Review Advisor, Patient Safety at AstraZeneca

Bengaluru, karnataka, India -

Full Time

Start Date

Immediate

Expiry Date

03 Jul, 26

Salary

0.0

Posted On

04 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Pharmacovigilance, Regulatory reporting, Adverse event reporting, Safety database management, Audit preparation, Regulatory compliance, Risk assessment, MedDRA coding, WHODrug coding, Quality assurance, Process improvement, Data quality control, Regulatory guidance interpretation, Mentorship, E2B submissions, EudraVigilance

Industry

Pharmaceutical Manufacturing

Description

Job Title: Regulatory Review Advisor, Patient Safety GCL : C3 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 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. 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 it’s always been done—so 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 progress—step forward and make your impact today! Date Posted 04-Apr-2026 Closing Date 06-Apr-2026 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. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

Responsibilities

The Regulatory Review Advisor ensures accurate and timely submission of safety reports to health authorities while maintaining compliance with global pharmacovigilance standards. They collaborate with cross-functional teams to interpret regulatory requirements and support audit readiness through robust documentation and process improvement.