Senior Safety Scientist Lead - Global PV & Equity Rewards

AstraZeneca plc; Boston (MA); On-site; USD 132,000 - 190,000; Full time

Benefits offered by this job

Short-term incentives

Equity awards

Commissions

Retirement plan

Paid time off

Health insurance

Dental insurance

Vision insurance

Job summary

AstraZeneca plc in Boston, MA seeks a Senior Manager, Safety Scientist to lead safety risk evaluation and management across the lifecycle of assigned products. You will collaborate with GPS Medical Directors and cross-functional teams to ensure compliance with global regulations, GxP, AZ procedures, and ethical standards.

The role covers safety data reviews, preparation of safety documents, aggregate safety reports, safety governance, risk management plans, and support for regulatory filings.

Qualifications

• Bachelor’s degree in a biologic/medical/clinical/nursing field.
• At least 3 years' 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.
• Sound judgement and ability to interact with multiple disciplines globally.
• Office-based role with typical business hours.

Responsibilities

• Contribute to safety data reviews and analyses for products in designated therapeutic areas.
• Author/review safety sections of clinical documents (ICS, ICF, IBR, SAP, CSR, DMC docs).
• Coordinate and complete high-quality aggregate safety reports (PSUR, PBRER, PADER) for regulatory submission.
• Oversee safety for assigned assets; implement Safety Strategy and Governance structures.
• Lead program and study level safety surveillance; analyze and communicate results.
• Author and manage health authority queries.
• Maintain risk management plans and contribute to REMS documents.
• Assist GPS Medical Directors in risk management strategy development.
• Train and manage junior safety scientists and fellows.
• Support regulatory filings including eCTD modules, CCDS, and local labels.
• Collaborate with Global Safety Physicians on regulatory strategies.
• Drive timely execution of safety documents; ensure governance and timelines.
• Contribute to standardized safety analytics and templates.
• Represent GPS as a subject-matter expert in study teams and cross-functional meetings.
• Seek process improvements and cross-departmental consistency.
• Maintain up-to-date knowledge of evolving global regulations.

Skills

Analytical and problem-solving skills

Excellent communication and Interp.

Scientific writing skills

Learning agility and independence

Interdisciplinary collaboration

PV impact awareness

Education

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

Advanced degree in biologic/medical/clinical/nursing

Tools

Power BI

Spotfire

Clinical and safety databases

Job description

AstraZeneca plc in Boston, MA seeks a Senior Manager, Safety Scientist to lead safety risk evaluation and management across the lifecycle of assigned products. You will collaborate with GPS Medical Directors and cross-functional teams to ensure compliance with global regulations, GxP, AZ procedures, and ethical standards.

The role covers safety data reviews, preparation of safety documents, aggregate safety reports, safety governance, risk management plans, and support for regulatory filings.