Associate Director, Senior Patient Safety Scientist

AstraZeneca plc; Gaithersburg (MD); On-site; USD 140,000 - 190,000; Full time

Job summary

AstraZeneca plc in Gaithersburg, MD seeks an Associate Director, Senior Patient Safety Scientist to lead safety data reviews, author PV input for regulatory reports, and present analyses to the Global Safety Physician and safety teams.

You will drive proactive pharmacovigilance and risk management planning, oversee complex safety sections in trial documents and regulatory submissions, mentor junior staff, and collaborate across functions to ensure compliance with ICH and US/EU/UK PV regulations.

Qualifications

• Life sciences/pharmacy/nursing degree required.
• Advanced knowledge of PV regulations.
• Substantial pharma/biotech/CRO experience in patient safety/pharmacovigilance.
• Experience in clinical safety in development, signal management, PSURs/DSURs, and safety sections of protocols/IBs/ICFs/CSRs.
• Good knowledge of US/EU/UK PV regulations and ICH guidelines.
• MD/MSc/PhD preferred.
• Epidemiology understanding preferred.

Responsibilities

• Leads and/or conducts proactive pharmacovigilance and risk management planning for complex products.
• Leads PS activities of cross-functional project teams for developmental compounds or marketed products.
• Leads safety inputs to Investigator Brochures, Protocols, Informed Consents and CSRs.
• Acts as Safety Strategy and Management Team (SSaMT) Leader for larger projects.
• Presents complex safety issues to SIRC and collaborates with GSP and stakeholders.
• Authors or provides input for multiple regulatory documents (PBRERs, PSURs, DSURs).
• Authors or provides strategic leadership for regulatory submissions (NDA/BLA, MAA).

Skills

PV regulations

Safety data review

Cross-functional leadership

Mentoring

Education

Life sciences/pharmacy/nursing degree

MD/ MSc/ PhD preferred

Job description

Introduction

The Associate Director, Senior Patient Safety Scientist role leads the review of safety data and related documents for potential safety issues in collaboration with the Global Safety Physician (GSP) and (Associate) PV Scientist. He/she authors and leads PV input to safety documents and regulatory reports. Associate Director, Senior Patient Safety Scientist leads meetings and presents safety data and analyses.

Main Responsibilities

• Leads and/or conducts proactive pharmacovigilance and risk management planning for more complex products, including preparation of the safety aspects of Global Risk Management Plans and Risk Evaluation and Mitigation Strategies (REMS) in partnership with the GSP and others as appropriate.
• Leads PS activities of cross-functional project teams for developmental compounds and/or marketed products.
• Leads and provides safety expertise to Investigator Brochures, Protocols, Informed Consents and Clinical Study Reports.
• Has the ability to perform duties as a Safety Strategy and Management Team (SSaMT) Leader for larger or more complex projects.
• Presents complex issues to Safety Information Review Committee (SIRC) and takes the lead role in data evaluation and discussion of the results with the SIRC Chair, GSP and other key stakeholders.
• Leads the collaboration with GSP and Clinical representatives and authors the Reference Safety Information (RSI) for multiple or complex development products.
• Authors/provides strategic input or oversight for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
• Authors/provides strategic leadership to regulatory submissions for new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts.
• Participates in negotiations and provides expertise to the PS component of contracts/agreements with third parties to ensure quality and integrity of agreements.
• Trains and mentors junior members of the team, e.g. in approved PV processes, analytic methodologies, etc.

Requirements – Education and Experience

• A life sciences/pharmacy/nursing degree, and demonstrated Patient Safety and/or Clinical/ Drug Development experience
• Advanced knowledge of PV regulations
• Substantial pharmaceutical, biotechnology or CRO experience in patient safety/pharmacovigilance and drug development, with experience independently delivering safety-science activities.
• Experience in at least 2 (two)of the following: clinical development safety; signal management; periodic safety reports; safety sections of protocols/IBs/ICFs/CSRs; regulatory responses.
• Good knowledge of US, EU and UK pharmacovigilance regulations and ICH guidelines.
• MD/MSc/PhD in scientific discipline, preferred
• Intermediate understanding of epidemiology, preferred

Date Posted

05-Nov-2026

Closing Date

30-Nov-2026

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.