Medical Director- Patient Safety Physician

Job Title: Medical Director, Patient Safety Physician

GCL: F

Introduction to role:

Are you ready to lead clinical safety strategy that protects patients while accelerating the delivery of life-changing medicines? Step into a pivotal role that shapes risk management, safety surveillance, and regulatory outcomes across a diverse, global development portfolio.

You will join a team that grows with evidence, collaboration, and continuous learning. Your clinical judgment and strategic direction will influence key decisions from early development through submissions, ensuring safety is embedded at every stage of the journey. Imagine guiding complex safety signals into clear actions that earn trust from regulators and unlock progress for patients.

Accountabilities:

Safety Governance and Risk Management: Review and endorse Patient Risk Management Plans; drive risk-minimisation strategies; and provide strategic clinical safety input into development planning so that safety is proactively designed into studies and programs.

Cross-Functional Leadership: Represent Patient Safety on Clinical Teams and Project Teams; facilitate Safety Management Team and Safety Review Team activities; and integrate safety requirements into core documentation to enable swift, aligned delivery.

Signal Detection, Evaluation, and Labelling: Lead end-to-end safety surveillance; shape the use of information sources and database searches; direct fit-for-purpose safety evaluations; and partner with stakeholders to translate data into precise labeling strategies. How will you turn complex signals into clear, patient-focused decisions?

Regulatory Reports and Submissions: Provide medical input for periodic reports and renewals; and contribute authoritative patient safety content to global submissions, ensuring clarity, robustness, and regulatory confidence.

External Engagement and Agreements: Contribute to Patient Safety components of Safety Agreements; advise on licensing arrangements; and represent Patient Safety in external regulatory and non-regulatory meetings to broaden influence and accelerate outcomes.

Continuous Improvement and Mentoring: Participate in process improvement initiatives; uphold inspection readiness; escalate issues to senior leadership with integrity; and foster cross-functional, cross-cultural collaboration that advances how we work.

Essential Skills/Experience:

• Reviews and endorses the core Patient Risk Management Plan (PRMP)
• Represents PS on cross-functional Clinical Teams and/or Project Teams
• Provides medical input to ensure risk-minimisation strategies are implemented appropriately
• Provides strategic clinical safety input into Clinical Development planning activities
• Provides strategic and medical input to project-specific safety requirements (PSSR)
• Reviews and provides technical input and approval for investigator brochures, protocols, informed consents, final study reports, and external data monitoring committees
• Provides input on cross-functional ad-hoc teams set up to address urgent and important safety issues
• Facilitates establishment of a Safety Management Team Safety Review Team as necessary
• Involved in all safety surveillance activities
• Provides medical input to regulatory supporting documentation for labelling updates
• Provides medical input into identification and utilization of appropriate sources of information and database searches
• Collaborates with external provider representatives in routine signal management activities
• Discusses the results of data evaluation with the Surveillance Team and/or appropriate key stakeholders
• Provides medical input to deliver accurate and fit-for-purpose safety evaluation documents
• Provides strategic input into responses to regulatory requests for local label deviations
• Provides medical input and review of periodic reports (e.g., PBRERs, PSURs, DSURs) and renewal documentation submitted to regulatory agencies
• Provides the patient safety contribution to global regulatory submissions (NDA, BLA, MAA etc.)
• Contributes to and/or reviews the PS component of Safety Agreements
• Advises on the preparation of licensing agreements in therapeutic area of responsibility
• Participates in AZ internal meetings with project focus
• Participates in external regulatory and non-regulatory meetings including those with consultants and other companies such as licensing partners
• Accountable for maintaining personal readiness in response to internal audit or regulatory inspection
• Participates in a process improvement initiative team within PS
• Advances concerns/issues to senior management in a timely, open, and appropriate manner; ensures quality and integrity of issue/event being raised
• Collaborates effectively in cross-functional and cross-cultural project teams and environments, and works with external providers

Desirable Skills/Experience:

• May present safety information at clinical investigator and commercial meetings
• May prepare the Developmental Core Safety Information (DCSI) for assigned development products
• May assist in due diligence activities
• May provide support to AZ Legal for product liability litigation, as appropriate
• May lead a process improvement initiative team within PS
• May mentor and train junior members of the team in signal evaluation methodology, risk management, and preparation of safety reports and other documents

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.

Why AstraZeneca:

This is where scientific difficulty meets courageous decision-making, and where your safety leadership can reshape the path from discovery to medicine. You will collaborate with diverse experts who share, learn, and challenge together—transforming evidence into action while embracing setbacks as learning moments. We bring unexpected teams together to unlock bold ideas, value kindness alongside ambition, and empower you to influence programs that address complex, unmet needs. Your work will help medicines reach people who need them—at scale—while you grow through real responsibility, modern tools, and a culture that celebrates clear thinking and purposeful impact.

If you are ready to steer safety strategy that protects patients and accelerates breakthrough medicines, take the next step and express your interest 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.