Regulatory Reporting Advisor Patient Safety

Job Title: Regulatory Reporting Advisor - Patient Safety

Career Level: C

Introduction to role:

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 confidencetranslating 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:

Regulatory Documentation & Submissions

• 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 fulltext articles from approved sources libraries databases publishers journal subscriptions and open-access platforms.

Regulatory Reporting Compliance

• 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

General

• 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

Essential Skills/Experience:

• Bachelors 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 authoritys regulations

• Cross functional collaborative approach

• Effective and lateral thinking

• Problem solving

• Vendor management

• Excellent attention to detail

• Excellent written and verbal communication skills

Desirable Skills/Experience:

• 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 -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 the enterprisebringing 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 performancestep 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.