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 activities
• 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
• May present safety information at clinical investigator and commercial meetings
• Facilitates establishment of a Safety Management Team Safety Review Team as vital

Signal Detection, Evaluation, and Labelling

• 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 collaborators
• 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
• May prepare the Developmental Core Safety Information (DCSI) for assigned development products

Regulatory Reports and Submissions

• 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
• May assist in due diligence activities
• May provide support to AZ Legal for product liability litigation, as appropriate
• Accountable for maintaining personal readiness in response to internal audit or regulatory inspection
• Participates in, and may lead, a process improvement initiative team within PS
• May contribute to advancement of methodology and process by generating new ideas and proposals for implementation
• Advances concerns/issues to senior management in a timely, open, and appropriate manner; ensures quality and integrity of issue/event being raised
• May mentor and train junior members of the team in signal evaluation methodology, risk management, and preparation of safety reports and other documents
• Collaborates effectively in cross-functional and cross-cultural project teams and environments, and works with external providers.

Essential Skills/Experience:

• Medical degree or equivalent experience (e.g., MD, MBBS)
• At least 2 years of clinical experience post-registration preferred
• Clinical experience or pharmaceutical industry of nuclear medicine/Radioligand Therapy will be preferred
• High level of medical competence, with an ability to balance this with industry standards to achieve business goals
• Up to 11-13 years of Patient Safety experience (with clear evidence of delivery)
• Total 16 years of experience
• A thorough knowledge of the pharmaceutical/biopharmaceutical industry, especially clinical research and global regulatory requirements and practices governing expedited and periodic safety reporting, signal generation, safety evaluation, and risk management activities.
• Commitment to Customers and Integrity (represents and shapes customer perspectives)
• Strategic Leadership (identifies untapped opportunities)
• Acts Decisively (create clarity for others to act decisively)
• Drives Accountability (creates cross-boundary accountability)
• Works Collaboratively (establishes shared purpose across boundaries)
• Develops People and Organisation (invests in long-term development of others)
• Drug Development Experience and Application of Disease and TA knowledge
• Integrative thinking
• Excellence in pharmacovigilance
• Patient Benefit risk assessment

Desirable Skills/Experience:

• Conceptual thinking (associates seemingly unrelated information, analyses situations, takes long term view)
• Influencing (presents positive image, demonstrates flexibility, effectively facilitates communication applies negotiation strategies and tactics, to reach conclusion)
• Initiative (acts proactively, proposes improvements where appropriate)
• Innovation (stays current on emerging trends and new practices within relevant areas)
• Business relationship management (demonstrates good knowledge of relevant specialist area, develops strategic and collaborative relationships)

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

28-Jan-2026

Closing Date

26-Feb-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 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 authorisation and employment eligibility verification requirements.