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Astrazeneca1 month ago

Associate Director, Safety Scientist

$126,000–$190,000 year

On-site · Boston, Massachusetts, United States

Type
Full Time
Level
Mid Level
Education
Bachelors Degree
Company size
Enterprise

Job Summary

The Associate Director, Safety Scientist leads efforts in global patient safety, managing safety activities across product portfolios, and providing guidance on regulatory compliance. Responsibilities include preparing safety documents, conducting signal surveillance, and training junior safety personnel, with a focus on enhancing safety analytics and risk management strategies.

Required Qualifications

  • Bachelor's degree in a biologic/medical/clinical/nursing field
  • At least 5 years' experience in drug safety and risk management
  • Knowledge and understanding of US and EU safety regulations pre- and post- marketing
  • Experience preparing post marketing safety regulatory documents including PSURs, PBRERs and Risk Management Plans
  • Experience with Risk Management and Minimization programs
  • Strong clinical, analytical, problem solving and scientific writing and communication skills
  • Ability to interact effectively with people of multiple disciplines and cultures
  • Expertise with Microsoft Word, PowerPoint, SharePoint and Excel

Desired Qualifications

  • Advanced degree in a biologic/medical/clinical/nursing field preferred: Pharmacist/PharmD, Nurse Practitioner or PhD
  • Expertise with clinical and safety databases
  • Experience in MedDRA coding and search strategies
  • Knowledge of Power BI, and other visualization tools
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$126k – $190k / yr

Associate Director, Safety Scientist · Astrazeneca

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