Global Safety Strategy Lead – Senior Scientist

AstraZeneca; Boston (MA); On-site; USD 126,000 - 190,000; Full time

Benefits offered by this job

Short-term incentives

Equity-based awards

Retirement plan

Health, dental, and vision coverage

Job summary

AstraZeneca is seeking an Associate Director, Safety Scientist to provide strategic leadership within Global Patient Safety. Based in Boston, MA, you will lead safety reviews, author safety sections in protocols and reports, and oversee safety communications with regulators, while mentoring junior scientists.

You will shape safety strategy, manage cross-functional teams, and ensure compliance with global regulations, GxP and AZ procedures, across the product lifecycle.

Qualifications

• Bachelor's degree in a biologic/medical/clinical/nursing field
• 5+ years of pharmaceutical industry drug safety/pharmacovigilance
• Subject matter expertise in global pharmacovigilance regulations and aggregate safety reports

Responsibilities

• Lead safety data reviews and analyses for products in designated therapeutic areas
• Author safety sections of clinical documents (protocols, ICFs, IBs, SAPs, CSR, DMC documents)
• Coordinate and prepare high-quality aggregate safety reports (PSUR, PBRER, PADER) for regulators
• Oversee safety for assets, implementing Safety Strategy and SST/SSaMT
• Lead safety surveillance and communication of results in cross-functional settings
• Author and manage health authority queries and contribute to REMS documents
• Develop risk management strategies with GPS Medical Directors
• Represent Global Patient Safety at regulatory inspections (MHRA, FDA, EMA)
• Mentor and manage junior safety scientists and fellows
• Support regulatory filings including eCTD modules and local labels
• Proactively drive safety governance, timelines and cross-functional engagement
• Contribute to standardized safety analytics and reporting processes
• Be a subject matter expert in clinical study teams and cross-functional meetings
• Assist process improvements and global regulatory knowledge growth

Skills

Pharmacovigilance expertise

Global regulations

Safety surveillance

Education

Bachelor's degree in biologic/medical/clinical/nursing

Tools

MedDRA coding

Power BI/Spotfire

Job description

AstraZeneca is seeking an Associate Director, Safety Scientist to provide strategic leadership within Global Patient Safety. Based in Boston, MA, you will lead safety reviews, author safety sections in protocols and reports, and oversee safety communications with regulators, while mentoring junior scientists.

You will shape safety strategy, manage cross-functional teams, and ensure compliance with global regulations, GxP and AZ procedures, across the product lifecycle.