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Senior Clinical Safety Specialist

1 month ago


Cambridge, Massachusetts, United States Apnimed Full time

Transforming Sleep Apnea Treatment

Apnimed, a clinical-stage pharmaceutical company, is seeking a highly skilled Senior Clinical Safety Scientist to join our team. As a key member of our Clinical Development and Safety teams, you will play a critical role in performing analytical software-driven clinical safety data analysis at both the individual participant and aggregate level.

Key Responsibilities:

  • Safety Data Analysis: Analyze and summarize safety data from ongoing and completed studies, providing actionable insights and recommendations at both the individual participant and aggregate levels.
  • Data Visualization and Analytics: Utilize data analytic and visualization tools to represent, explain, and document complex safety information in near real-time.
  • Signal Detection Strategy Development: Design and implement tailored signal detection strategies for assigned products to identify and evaluate safety signals effectively.
  • Regulatory Submission Support: Contribute to writing and reviewing safety and pharmacovigilance content for regulatory submissions, including NDA submission and FDA Information Request responses, collaborating with cross-functional teams as needed.

Requirements:

  • PharmD, RN, MD or equivalent healthcare-related degree.
  • Minimum 6 years of relevant pharmaceutical development experience, including at least 3 years of experience in software-driven safety data analysis.
  • Experience in implementing and reviewing cumulative safety data with ability to interpret, synthesize and communicate complex safety information, including use of data analytic and visualization tools, and interpretation of statistical results.
  • 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.
  • Knowledge of US drug development regulations and guidelines; knowledge of regulations in other regions is a plus.
  • Independently motivated, detail oriented and strong problem-solving ability.
  • Excellent organizational skills and demonstrated ability to multi-task in a fast-paced environment with changing priorities.
  • Excellent written and verbal communication skills with the ability to interact across multiple functions.

What We Offer:

  • 401(k) with company match.
  • Generous time off for vacation.
  • Generous healthcare benefits.
  • Flexible working environment.
  • Motivated and experienced team.

Location and Other Information:

  • 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.