Clinical Trial Safety Scientist

Job Description: • Collaborate closely with the team to review critical and pre-specified medical (primarily safety) data in clinical trials.
• Generate and manage documents following applicable procedures and best practices, and configure relevant tools.
• Continuously review patient-level clinical/safety data to ensure medical accuracy, completeness, and coding consistency.
• Generate queries as needed for appropriate medical assessment and case closure.
• Schedule and facilitate various types of meetings.
• Create visualizations using relevant tools and prepare slides, reports, and data as required.
• Contribute to non-drug project work, including continuous improvement and development of procedures as needed.
• Update study statuses in the tracker for studies per Therapeutic area upon request.
Educational Requirements:
• BSc/MSc/PhD in Life Science or equivalent work experience in directly related fields (preferably medicine, pharmacy, biotechnology, nursing, or dentistry).
Experience:
• Minimum 3+ years of experience in Pharmacovigilance, working on clinical studies and/or study safety methodology.
• Good knowledge of ICH/GCP Guidelines.
• Good Knowledge of SAE reporting requirements.
• Computer proficiency with some programming/data science experience (essential: MS Excel, PowerPoint; asset: PowerBI, R-programming, Python).
• Strong attention to detail, analytical skills, and the ability to concisely summarize large amounts of complex information.
• Ability to multi-task in a high-volume environment with shifting priorities.
• Excellent time management skills.
• Team player with the ability to work independently.

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