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Senior Clinical Safety Specialist
2 months ago
We are seeking a highly skilled Clinical Safety Specialist to join our team at Apnimed, a clinical-stage pharmaceutical company dedicated to transforming the treatment of sleep apnea.
As a key member of our Clinical Development and Safety teams, you will play a critical role in ensuring the safety and quality of our clinical trials. Your expertise will be instrumental in overseeing safety data collection and quality control, performing clinical safety data analysis, and participating in internal and external reporting.
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.
- 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, interpreting, synthesizing, and communicating complex safety information.
- Knowledge of US and global safety and pharmacovigilance regulations and guidelines.
- In-depth knowledge of Good Clinical Practice (GCP) and regulatory requirements.
- 401(k) with company match.
- Generous time off for vacation.
- Generous healthcare benefits.
- Flexible working environment.
- Motivated and experienced team.
