Medical Director, Patient Safety Physician

Job Title: Medical Director, Patient Safety Physician
Introduction to role
As a Medical Director, Patient Safety Physician at AstraZeneca, you will be responsible for the Clinical Safety strategy for assigned drug projects and products throughout all stages of development and/or when on the market. You will ensure the continued safety assessment, evaluation, and risk management of our products, predicting and managing their safety profiles. Your role will involve consistent communication of safety topics across all regulatory safety documents and proactive implementation of risk management initiatives in accordance with global regulatory requirements. You will work collaboratively with experts from across AstraZeneca to promote high-quality evaluation of safety data and contribute to the maintenance of the pharmacovigilance system and processes.
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 necessary
  

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 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
• 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.)
  

Other Activities

• 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
• 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

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• 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
  

Leadership (Target level 3):

• 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)
  

Technical (Professional level):

• Drug Development Experience and Application of Disease and TA knowledge
• Integrative thinking
• Excellence in pharmacovigilance
• Patient Benefit risk assessment
  

Desirable Skills/Experience
Core (Professional level):

• 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 unleash 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. 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.
At AstraZeneca, we push the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. Our commitment to patients is embedded in everything we do. We foster a mindset of courage where everyone is empowered to innovate. With one of the broadest Oncology pipelines in the industry, there are many opportunities to work with new drugs and help discover whats next.
Ready to make a difference? Apply now!