Are you ready to turn complex literature and safety data into timely, compliant regulatory submissions that protect patients and strengthen trust? In this role, you will be a key partner enabling our teams to move faster and deliver with confidence—translating evidence into action that stands up to inspection.
You will work at the intersection of science, regulation, and enterprise performance, guiding how we capture, assess, and report safety information across markets. Can you see yourself orchestrating literature surveillance, reportability decisions, and submissions that consistently meet global standards? Your impact will be felt in every compliant report, every audit-ready trail, and every patient protected.
Accountabilities:
Prepare, review, and submit regulatory reports, ensuring the complete, accuracy, and compliance within legal requirements
Maintain documentation for regulatory audits and inspections
Collaborate with cross-functional teams (e.g. Quality Assurance, Medical Affairs, Client PS Teams) to ensure alignment on regulatory reporting requirements
Evaluate literature citations to confirm relevance, accuracy, and completeness of safety-related content.
Perform literature case reconciliation to ensure all cited articles, abstracts, and publications are reviewed and matched correctly with internal safety case listings.
Retrieve and procure full‑text articles from approved sources, libraries, databases, publishers, journal subscriptions, and open-access platforms.
Assess each Literature article to determine regulatory reportability in alignment with FDA guidelines and company SOPs.
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
Adverse Event and Safety Reporting
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
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:
Relevant country regulatory authority regulations
Global and local procedural and guidance documents
Conditions, obligations and other commitments relating to product safety or the safe use of AZ products
Maintain accurate documentation, audit trails, and version control for all reviewed literature
Bachelor's degree in pharmacy, Life Sciences, Regulatory Affairs, or a related field
3 years + of experience in regulatory affairs, pharmacovigilance or regulatory reporting in the pharmaceutical industry
Pharmacovigilance knowledge excellence including literature analysis
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
PV Regulatory Reporting experience
Medical knowledge in company Therapeutic Areas
Successful participation in above-market projects
Audit & Inspection experience
When we put unexpected teams in the same room, we fuel 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.
Here, your expertise powers the enterprise—bringing together a diverse set of minds to solve complex problems and accelerate how we safeguard patients. You will work with colleagues who challenge assumptions, share knowledge generously, and embrace exciting technologies to reimagine our processes. We value kindness alongside ambition, and we back curiosity with real investment in learning, so you can grow your impact while helping us move faster, make better decisions, and deliver safety insights that matter.
Bring your regulatory reporting expertise to a team where your work protects patients and elevates performance—step forward and make your impact today!
Date Posted
09-Mar-2026Closing 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.