Medical Director, Patient Safety Physician

AstraZeneca•Gaithersburg, MD

10d•$249,827 - $374,741•Hybrid

About The Position

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. 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. 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. Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention. The Role: The Medical Director, Senior Patient Safety Physician leads the Clinical Safety strategy for assigned AstraZeneca-MedImmune products across development and post‑marketing, ensuring implementation and communication at project/governance levels. The role oversees ongoing safety assessment, signal detection, risk evaluation and management, and consistent communication across regulatory safety documents (e.g., PBRERs, PADERs, DSURs). It includes proactive evaluation of safety data from pre‑clinical and clinical sources, collaboration with cross‑functional experts and Safety Management Teams, contribution to the pharmacovigilance system (including QPPV interface), and engagement with external opinion leaders. The principal accountabilities/responsibilities are summarized below:

Requirements

Medical degree (eg MD, MBBS) from any accredited university across the world
At least 1+ years of clinical experience post-registration
High level of medical competence, with an ability to balance this with industry standards to achieve business goals
At least 5 years of Drug Development/Patient Safety experience (the majority of which should be in industry in Patient Safety) with clear evidence of delivery
A thorough knowledge of the pharmaceutical/ biopharmaceutical industry, especially clinical research and global regulatory requirements (eg BLA, NDA or MAA) and practices governing expedited and periodic safety reporting, signal generation, safety evaluation and risk management activities
NB: It is not mandatory to meet the minimum requirements for length of experience or to have completed the UK Higher Medical Training in Pharmaceutical Medicine; these details are intended to be indicative of the level of knowledge, expertise and recognition required of an individual in this job.

Nice To Haves

UK physicians will generally be expected to have completed Higher Medical Training in Pharmaceutical Medicine
MSc/PhD in scientific discipline
Able to work across TAs and Functions
Experience of supervising Patient Safety colleagues
A demonstrated ability to understand epidemiological data

Responsibilities

Working with the Safety Team, be responsible for the Clinical Safety strategy for assigned AstraZeneca-MedImmune drug projects and products throughout all stages of development and/or when on the market, including implementation and communication of the safety strategy at the project team/governance level. Activities include, but are not limited to: definition of identified and potential risks, proposals for mitigation and minimisation measures,, safety go-no-go criteria for the clinical programme, input to TPP/TPC,, safety submission strategies, response to regulatory safety queries and definition of risk component of the benefit/risk assessment
Reviews and endorses the core Patient Risk Management Plan (PRMP)/Core Patient Risk Log (CPRL).
Provides expertise to the medical content of the safety specification, pharmacovigilance plan and risk minimisation activities in the core PRMP, MedImmune dRMP, CPRL and globally reviewed LRMPs.
Represents PS on cross-functional Clinical Teams and/or Project Teams for developmental and/or marketed products.
Leads medical input to ensuring that risk-minimisation strategies are implemented appropriately in relevant documents such as product reference safety information.
Leads strategic clinical safety input into Clinical Development planning activities in accordance with PS Operating Model and Science Unit Service Level agreements.
Leads 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 as appropriate.
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/MedImmune Safety Review Team as necessary.
Involved in all safety surveillance activities, may include medical review of individual safety cases (providing medical expertise and judgement), signal detection, evaluation and SERM activities (or Medimmune equivalent) for all products in area or responsibility.
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 to retrieve relevant data for evaluation of signals.
Sets the strategy for routine signal management activities.
Presents the results of data evaluation with the Surveillance Team and/or appropriate key stakeholders, eg Patient Safety VP TA, QPPV/Deputy QPPV.
Provides medical input to deliver accurate and fit for purpose safety evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data.
Provides strategic input into responses to regulatory requests for local label deviations from the company core safety documentation
In consultation with the PS scientist and Clinical representatives, prepares the Developmental Core Safety Information (DCSI) for assigned development products.
Provides medical input and review of periodic reports (eg PBRERs, PSURs, DSURs) and renewal documentation submitted to regulatory agencies.
Leads the patient safety contribution to global regulatory submissions (NDA, BLA, MAA etc) for new products, formulations or indications.
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.
Raises concerns/issues to senior management in a timely, open and appropriate manner; ensures quality and integrity of issue/event being escalated.
May mentor and train junior members of the team in signal evaluation methodology, risk management and preparation of safety reports and other documents.

Benefits

positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program.
Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

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