Senior Clinical Safety Specialist

7 days ago


Cambridge, Massachusetts, United States Apnimed Full time
Senior Clinical Safety Scientist

Apnimed is a clinical-stage pharmaceutical company dedicated to transforming the treatment of sleep apnea. We are seeking a highly skilled Senior Clinical Safety Scientist to join our team.

Key Responsibilities:
  • Oversee safety and pharmacovigilance activities, ensuring data quality control and effective management of adverse events.
  • Analyze and summarize safety data from ongoing and completed studies, providing actionable insights and recommendations.
  • Design and implement tailored signal detection strategies for assigned products to identify and evaluate safety signals effectively.
  • Utilize data analytic and visualization tools to represent, explain, and document complex safety information in near real-time.
  • 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 with ability to interpret, synthesize and communicate complex safety information.
  • Demonstrated ability to develop, execute and follow-through complex projects to completion.
  • Skilled at working effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
What We Offer:
  • 401(k) with company match
  • Generous time off for vacation
  • Generous healthcare benefits
  • Flexible working environment
  • Motivated and experienced team

Apnimed is a privately held company based in Cambridge, MA. We are generally virtual, and specific location within the US is flexible, but must be able to travel as necessary. Apnimed is an EEO employer committed to an exciting, diverse, and enriching work environment.



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