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AstraZeneca

Medical Director, Senior Safety Physician

AstraZeneca, Gaithersburg, Maryland, us, 20883

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Overview

Medical Director, Senior Patient Safety Physician — you are a senior leader within Patient Safety, providing deep clinical understanding and judgement in benefit-risk assessments for AstraZeneca products. You will shape the culture of the department, coach and mentor junior Patient Safety staff, and ensure projects adhere to Good Clinical and Pharmacovigilance Practice and regulatory requirements. You should follow medical developments to incorporate emerging data and trends into the safety strategy. Responsibilities

Providing strategic Patient Safety input to drug development and post-marketing programs Collaborating with team members to undertake safety surveillance activities and prepare high-quality evaluation documents describing 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 the Patient Safety Peer Review Committee Leading the safety strategy for regulatory communication and overseeing higher-level documents to support submission activities Leading medico-scientific contributions to Risk Management Plans (RMPs) for assigned products and to Periodic Reports, including PBRERs and DSURs Participating in advisory discussions to support other Patient Safety teams in developing their safety strategy and representing Patient Safety in cross-functional discussions with internal and external partners Minimum Requirements

MBBS/MD or equivalent medical qualification; experience as a physician or academic clinician 7+ years of proven experience Extensive experience in Pharmacovigilance with demonstrated delivery to a high standard Detailed understanding of pharmaceutical safety, reporting and surveillance processes with strong experience in Patient Safety related to clinical trials and marketed products Experience in designing, supervising and implementing clinical trials and interpreting trial results Strategic leadership of complex drug projects Understanding of medico-legal aspects of pharmacovigilance Proven ability to lead cross-functional delivery teams and influence key business partners Proficiency in written and verbal communications Preferred

PhD in a scientific field 5+ years of proven experience beyond the minimum Therapeutic area expertise and commercial understanding Extensive general medical knowledge; ability to work across Therapeutic Areas and Functions Research background, including peer-reviewed publications Date Posted

03-Sept-2025 Closing Date

29-Nov-2025 EEO Statement

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

Director Employment type

Full-time Job function

Health Care Provider Industries

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