Senior Patient Safety Scientist - Associate Director

AstraZeneca; 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

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.