Medical Director, Senior Safety Physician
21 Days Old
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 Pharmaceutical Manufacturing
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- Location:
- Gaithersburg, MD, United States
- Job Type:
- FullTime
- Category:
- Bio & Pharmacology & Health