Senior Safety Scientist & Global PV Program Lead

AstraZeneca

Boston (MA)

Hybrid

USD 133,000 - 199,000

Full time

7 days ago
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Job summary

AstraZeneca seeks a Senior Manager, Safety Scientist to join Global Patient Safety, evaluating and managing safety risks across product lifecycles in collaboration with GPS Medical Directors and cross-functional teams. The role emphasizes high ethical and regulatory standards in global practice.

You will lead safety data reviews, author or review safety sections in key clinical docs, manage aggregate safety reports for regulators, and guide risk management and safety governance while mentoring

Qualifications

  • Bachelor's degree with at least 3 years in drug safety/pharmacovigilance.
  • Knowledge of global pharmacovigilance regulations and safety reporting.
  • Strong scientific writing, communication and analytical skills.
  • Ability to work independently and interact across cultures and functions.
  • Experience with risk management, regulatory filings, and safety governance.

Responsibilities

  • Contribute to safety data reviews and analyses for designated products.
  • Author or review safety sections in clinical documents and reports.
  • Coordinate high-quality aggregate safety reports (PSUR, PBRER, PADER).
  • Oversee safety strategy implementation and signal management activities.
  • Lead study- and program-level safety surveillance and cross-functional presentations.

Skills

Analytical thinking
Communication skills
Problem-solving
Independent work
Interpersonal skills
Good judgement
Cross-cultural collaboration

Education

Bachelor's degree in biological/medical/clinical/nursing
Advanced degree (PharmD/NP/PhD)

Tools

Power BI
Spotfire
Clinical safety databases

Job description

AstraZeneca seeks a Senior Manager, Safety Scientist to join Global Patient Safety, evaluating and managing safety risks across product lifecycles in collaboration with GPS Medical Directors and cross-functional teams. The role emphasizes high ethical and regulatory standards in global practice.

You will lead safety data reviews, author or review safety sections in key clinical docs, manage aggregate safety reports for regulators, and guide risk management and safety governance while mentoring

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