MD, Gaithersburg, US
11 days ago
Medical Director, Senior Safety Physician

As a Medical Director, Senior Patient Safety Physician, you are a senior leader within Patient Safety and play a key role bringing deep clinical understanding and judgement in benefit risk assessments for AstraZeneca products. You also have a role in shaping the culture of the department; and will act as a coach and mentor to more junior Patient Safety staff. You will also ensure projects adhere to Good Clinical and Pharmacovigilance Practice and regulatory requirements. We encourage you to closely follow medical developments within assigned areas to incorporate emerging data and trends into the safety strategy

Main Responsibilities:

Providing strategic Patient Safety input to drug development and post-marketing programsCollaboration with team members to undertake safety surveillance activities and prepare high quality evaluation documents to describe safety findings.Ensuring expert input to all elements of design and interpretation, including efficient use of tools and methodology (e.g. modelling and simulation).Providing leadership to support project discussions with governance boards, including interactions with Patient Safety Peer Review Committee.Lead the safety strategy for regulatory communication and provide oversight of higher-level documents to support submission activities.Lead medico-scientific contributions to RMPs for assigned products and to Periodic Reports, including PBRERs, DSURs.More broadly you are expected to participate in advisory discussions to support other Patient Safety teams in the development of their safety strategy and may be asked to represent Patient Safety in cross-functional discussions with internal and external partners.

Minimum Requirements:

BS degree in medicine and experience as a physician or academic clinician7+ years of proven experienceExtensive experience in Pharmacovigilance, with clear evidence of delivering to a high standardDetailed understanding of pharmaceutical safety, reporting and surveillance processes and strong experience of Patient Safety, as it relates to clinical trials and marketed products in any relevant field such as pharma, Regulatory Agency or Public Health agencyExperience in designing, supervising and implementing clinical trials and interpreting trial resultsStrategic leadership of complex drug projectsUnderstanding of the medico-legal aspects of pharmacovigilanceProven leader of cross-functional delivery teams.Demonstrated ability to influence key business partners within and outside of companyProficiency with both written and verbal communications

Preferred

PhD in scientific field5+ years of proven experienceTherapeutic area expertise and commercial understandingExtensive general medical knowledgeAble to work across TAs and FunctionsResearch background, including peer reviewed publications

Date Posted

03-Sept-2025

Closing Date

29-Nov-2025

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

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