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Senior Clinical Safety Specialist

2 months ago

Cambridge, Massachusetts, United States Apnimed Full time
About the Role

We are seeking a highly skilled Clinical Safety Specialist to join our team at Apnimed. As a key member of our Clinical Development and Safety teams, you will play a critical role in ensuring the safety of our clinical trials and the quality of our safety data.

Key Responsibilities
  • Drug Safety and Pharmacovigilance Support: Oversee safety and pharmacovigilance activities, ensuring data quality control and effective management of adverse events, including non-serious and serious events, adverse events of special interest, and signal detection across clinical laboratory, vital signs, and ECG data.
  • Safety Data Analysis and Recommendations: Analyze and summarize safety data from ongoing and completed studies, providing actionable insights and recommendations at both the individual participant and aggregate levels.
  • 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 (e.g., ISS, ISCRs, aggregate safety reports).
  • Regulatory Submission Collaboration: Contribute to writing and reviewing safety and pharmacovigilance content for regulatory submissions and responses, collaborating with cross-functional teams as needed.
  • Clinical Trial Safety Oversight: Act as a safety and quality resource for assigned clinical trials, ensuring participant safety and maintaining high medical and scientific standards throughout trial execution.
  • Adverse Event and Literature Review: Conduct thorough searches and reviews of adverse event data, scientific literature, and other safety-relevant information to support signal detection efforts.
  • Therapeutic Area Expertise: Provide clinical safety and pharmacovigilance support for Apnimed's developmental products, collaborating closely with Clinical, Safety, Regulatory, Pharmacovigilance, Data Management, and Biostatistics/Programming teams.
  • Data Monitoring Committee Support: Participate in and support the preparation for product-level Data Monitoring Committee meetings.
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, including use of data analytic and visualization tools such as Empirica, LifeSphere, JMP Clinical, or equivalent.
  • Experience in the preparation and authoring of individual and aggregate safety reports.
  • 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 and global safety and pharmacovigilance regulations and guidelines.
  • In-depth knowledge of Good Clinical Practice (GCP) and regulatory requirements.
  • 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.