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 highquality 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 crossfunctional Clinical Teams and/or Project Teams
Provides medical input to ensure riskminimisation strategies are implemented appropriately
Provides strategic clinical safety input into Clinical Development planning activities
Provides strategic and medical input to projectspecific 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 crossfunctional adhoc 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 fitforpurpose 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 nonregulatory 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 crossfunctional and crosscultural 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 postregistration preferred
High level of medical competence with an ability to balance this with industry standards to achieve business goals
Up to 1113 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

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 crossboundary accountability)
Works Collaboratively (establishes shared purpose across boundaries)
Develops People and Organisation (invests in longterm 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 lifechanging medicines. Inperson 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!

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 industryleading 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 nondiscrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.