Associate Director, Patient Safety Scientist Full-time

Associate Director, Patient Safety Scientist

Location: Gaithersburg, MD

At AstraZeneca, it is our bold ambition to achieve disease modification, clinical remission, and cure, to impact the lives of millions of people worldwide suffering from cardiovascular, renal, metabolic and respiratory diseases. We are now expanding our diverse pipeline to secure leadership in numerous BioPharma indications.

The Associate Director, Patient Safety Scientist role works collaboratively with the Global Safety Physician (GSP) and (Senior/Principal) PV Scientist with the review of safety data and related documents for potential safety issues. He/she has the ability to provide authoring and PV input to safety documents and regulatory reports. Associate Director, Patient Safety Scientist also has the ability to lead meetings and present safety data and analyses.

Main Responsibilities:

• Leads and/or conducts proactive pharmacovigilance and risk management planning for designated products, including preparation of safety aspects of Global Risk Management Plans, in partnership with the GSP and others as appropriate.
• Represents PS on cross-functional project teams for developmental compounds and/or marketed products.
• Has the ability to present safety information at external meetings.
• Has the ability to perform duties as a Safety Strategy and Management Team (SSaMT) leader for smaller or less complex projects.
• Presents issues to Safety Information Review Committee (SIRC) and has the capacity to take the lead role in data evaluation and discussion of the results with the SIRC Chair, GSP and other key stakeholders.
• Produces accurate and fit for purpose evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data.
• Collaborates with GSP and Clinical representatives and authors the Reference Safety Information (RSI) for assigned development products; coordinates meetings and tracks timelines to ensure completion.
• Proactively evaluates the clinical implications of safety data from pre-clinical studies, clinical studies, literature and other information sources to establish the safety profile of drugs and manage the risk to patients.
• Authors/provides strategic input or oversight for periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
• Authors/provides strategic input to regulatory submissions for new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts.
• Contributes to the PS component of contracts/agreements with third parties to ensure quality and integrity of agreement.
• Trains junior members of the team in PS tools and systems.

Education and Experience

Minimum Requirements:

• A life sciences/pharmacy/nursing MSc.PharmD, and demonstrated Patient Safety and/or Clinical/ Drug Development experience, with 1+ yrs industry experience.
• Intermediate knowledge of PV regulations
• Fluent in written and verbal English

Desired:

• MD, PhD in scientific discipline, preferred
• Basic understanding of epidemiology data, preferred

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.