Senior Medical Safety Expert

2 weeks ago


Pittsburgh, Pennsylvania, United States SSi People Full time

Position: Medical Safety Scientist

Work Arrangement: Fully Remote

Contract Duration: Long-term engagement with potential for extension

Essential Qualifications and Experience:

  • At least 8 years of expertise in pharmacovigilance, including a minimum of 5 years focused on risk assessment and management.
  • Proficient in independently navigating clinical safety and medical literature databases.
  • Comprehensive understanding of pharmacovigilance guidelines, safety documentation, and risk evaluation.
  • Exceptional medical writing capabilities and a track record of leading multidisciplinary teams.
  • Thorough knowledge of medical and pharmaceutical terminology, alongside the clinical development lifecycle.
  • Experience with MedDRA and safety data systems; adept with Windows software and quick to adapt to new applications/databases.

Educational Background:

  • A degree (BS, BA, MSc, or PhD) or equivalent professional qualification in a life sciences discipline (e.g., nursing or pharmacy) or a related scientific/technical field.

Primary Responsibilities:

  • Guide and support junior Medical Safety Scientists.
  • Develop safety strategies and lead cross-functional Safety Management Teams.
  • Manage signal detection and safety reporting workflows.
  • Ensure adherence to regulatory standards and readiness for inspections.
  • Contribute to international regulatory submissions and risk management strategies.
  • Provide insights on medical safety for clinical development and safety agreements.


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