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Associate Director, Senior Patient Safety Scientist
AstraZenecaGaithersburg, United Statesfull_timeVerifiedPosted 22 Apr 2025
💰 $190,487/yr($126,991/yr – $190,487/yr)
About the role
Are you ready to lead the charge in ensuring patient safety and making a real difference? As an Associate Director, Senior Patient Safety Scientist, you will spearhead the review of safety data and related documents for potential safety issues in collaboration with the Global Safety Program Lead, (GSPL). You will author and lead PV input to safety documents and regulatory reports, lead meetings, and present safety data and analyses. Join us in our mission to deliver life-changing medicines to patients worldwide.
Accountabilities
Lead and/or conduct proactive pharmacovigilance and risk management planning for more complex products, including preparation of the safety aspects of Global Risk Management Plans (RMP) and/or Risk Evaluation and Mitigation Strategies (REMS) in partnership with the GSPL and others as appropriate.
Lead PS activities of cross-functional project teams for marketed products and/or developmental compounds.
Provide safety expertise to Investigator Brochures and Protocols, Informed Consents, and Clinical Study Reports.
Present complex issues to the Safety Information Review Committee (SIRC) and take the lead role in data evaluation and discussion of the results with the SIRC Chair, GSPL, and other key partners.
Collaborate with GSPL and Clinical representatives to author the Reference Safety Information (RSI) for multiple or complex marketed products and/or development products.
Author/provide strategic input or oversight for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
Participate in negotiations and provide expertise to the PS component of contracts/agreements with third parties to ensure quality and integrity of agreements.
Train and mentor junior members of the team in approved PV processes, analytic methodologies, etc.
Author/provide strategic leadership to regulatory submissions for new products, formulations, or indications (NDA/BLA, MAA), in partnership with the GSPL and other functional experts.
Essential Skills/Experience
Qualified to degree level in biosciences or an equivalent healthcare or pharmaceutical industry background, with proven competency in patient safety/clinical development
Comprehensive understanding of applicable Patient Safety regulatory obligations
Awareness of Patient Safety policies, processes, and procedures
Awareness of medico-legal aspects of patient safety
11 to 13 years Patient Safety experience (Pharmacovigilance)
Total of 14 to 16 years of experience
Desirable Skills/Experience
Well-developed interpersonal skills
Cultural sensitivity
Ability to network with other functions globally
Site Description:
Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of BioPharmaceuticals and Oncology R&D in the US. Here, we play host to some of the most innovative technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration.
The Gaithersburg site offers a variety of amenities t
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