Senior Clinical Safety Specialist
3 weeks ago
Apnimed is a clinical-stage pharmaceutical company focused on developing novel pharmacologic therapies for sleep apnea and related disorders.
The Senior Clinical Safety Scientist plays a critical role in the Clinical Development and Safety teams, responsible for performing analytical software-driven clinical safety data analysis at both the individual participant and aggregate level.
This effort supports and engages with a wide range of other core safety activities, including clinical trial safety data collection, quality control, pharmacovigilance, and internal and external reporting.
The Senior Clinical Safety Scientist maintains up-to-date knowledge of drug development and regulatory expectations for data analysis to support new drug approval.
Key Responsibilities include:
- Analyzing and summarizing safety data from ongoing and completed studies, providing actionable insights and recommendations at both the individual participant and aggregate levels.
- Utilizing data analytic and visualization tools to represent, explain, and document complex safety information in near real-time.
- Designing and implementing tailored signal detection strategies for assigned products to identify and evaluate safety signals effectively.
- Contributing 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 include:
- 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.
- Training and at least 3 years of hands-on use of data visualization software such as JMP, Power BI, Tableau, or similar.
- 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.
Apnimed offers a collaborative team environment, flexible working arrangements, and opportunities for professional growth and development.
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