Global Safety Lead & Scientist

AstraZeneca GmbH; Boston (MA); Hybrid; USD 133,000 - 199,000; Full time

Benefits offered by this job

401(k) plan

Health benefits

Paid vacation

Job summary

AstraZeneca GmbH is seeking a Senior Manager, Safety Scientist to lead safety risk evaluation and management within Global Patient Safety, collaborating with Medical Directors and cross-functional teams across product lifecycles.

The role emphasizes high ethical and regulatory standards, oversight of safety governance, and liaison with regulatory bodies to ensure timely safety submissions and risk management strategies.

Qualifications

• Bachelor’s degree in a biologic/medical/clinical/nursing field with at least 3 years of experience in drug safety/pharmacovigilance.
• Knowledge of global pharmacovigilance regulations.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Strong scientific writing skills.
• Demonstrated learning agility and ability to work independently.

Responsibilities

• Contributing to safety data reviews and analyses for products in designated therapeutic areas.
• Authoring or reviewing safety sections of clinical documents including protocols, informed consent forms, and study reports.
• Coordinating and preparing high-quality aggregate safety reports for regulatory submission.
• Overseeing safety for assigned assets and implementing Safety Strategy and SST/SSaMT governance.

Skills

Safety data analysis

Analytical skills

Scientific writing

Communication skills

Independent work

Education

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

Tools

MedDRA

Power BI

Spotfire

Job description

AstraZeneca GmbH is seeking a Senior Manager, Safety Scientist to lead safety risk evaluation and management within Global Patient Safety, collaborating with Medical Directors and cross-functional teams across product lifecycles.

The role emphasizes high ethical and regulatory standards, oversight of safety governance, and liaison with regulatory bodies to ensure timely safety submissions and risk management strategies.