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Senior Clinical Safety Scientist
3 months ago
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.
Job Summary:The Senior Clinical Safety Scientist will play a critical role in the Clinical Development and Safety teams, overseeing clinical trial safety data collection and quality control, performing clinical safety data analysis, and participating in internal and external reporting. This position requires a strong background in clinical safety data analysis, pharmacovigilance, and regulatory affairs.
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.
- Contribute to writing and reviewing safety and pharmacovigilance content for regulatory submissions and responses, collaborating with cross-functional teams as needed.
- Act as a safety and quality resource for assigned clinical trials, ensuring participant safety and maintaining high medical and scientific standards throughout trial execution.
- 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.
- 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.
- 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.
