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Senior Clinical Safety Specialist

2 months ago

Cambridge, Massachusetts, United States Apnimed Full time
{"title": "Senior Clinical Safety Scientist", "subtitles": ["Clinical Safety Lead", "Safety Data Analyst", "Pharmacovigilance Expert"], "description": "Job Summary

Apnimed is seeking a highly skilled Senior Clinical Safety Scientist to join our Clinical Development and Safety teams. As a key member of our team, you will be responsible for performing core safety activities, including overseeing clinical trial safety data collection and quality control, performing clinical safety data analysis, and participating in internal and external reporting.

Key Responsibilities
  • Drug Safety and Pharmacovigilance Support: Oversee safety and pharmacovigilance activities, ensuring data quality control and effective management of adverse events.
  • Safety Data Analysis and Recommendations: Analyze and summarize safety data from ongoing and completed studies, providing actionable insights and recommendations.
  • Signal Detection Strategy Development: Design and implement tailored signal detection strategies for assigned products to identify and evaluate safety signals effectively.
  • Data Visualization and Analytics: Utilize data analytic and visualization tools to represent, explain, and document complex safety information in near real-time.
  • Safety Report Preparation: Assist in the preparation and authoring of individual and aggregate safety reports, ensuring accurate, timely, and high-quality contributions for regulatory submission documents.
Requirements
  • PharmD, RN, MD, or equivalent healthcare-related degree.
  • Minimum 6 years of relevant pharmaceutical experience, including at least 3 years of experience in clinical safety data analysis.
  • Experience in implementing and reviewing cumulative safety data, interpreting, synthesizing, and communicating complex safety information.
  • Demonstrated ability to develop, execute, and follow-through complex projects to completion.
  • Skilled at working effectively in a collaborative team environment.
What We Offer
  • 401(k) with company match.
  • Generous time off for vacation.
  • Generous healthcare benefits.
  • Flexible working environment.
", "location": "Cambridge, MA", "company": "Apnimed"}