Drug Safety Associate II

Position: Exelixis Drug Safety Associate II Role
Location: Quebec City

Join Exelixis as a Drug Safety Associate II, where you will leverage your expertise in safety data management and regulatory compliance. Your work will support critical safety case processing activities in a dynamic biotech environment.

In this position, you will oversee the management of serious adverse events from start to finish within the Argus Safety Database. You are expected to collaborate with multiple departments, ensuring safety data is accurately collected and documented. This requires strong analytical skills and a proactive approach to quality reviews as well as leading specific safety studies from initiation to closure.

Key Responsibilities:

• Handle serious adverse events from receipt to case closure

• Perform MedDRA coding consistent with Exelixis standards

• Ensure high-quality case reviews for robust safety documentation

• Work collaboratively with Clinical Development, Project Management

• Lead development of study safety management tools

Requirements:

• MS/MA in Nursing or relevant field with 3 years' experience

• Oncology background preferred for candidates

• Experience in clinical trial and adverse event processing

• Strong understanding of biotechnology and safety regulations

• Proficiency in clear verbal and written communication

Bring your drug safety knowledge to Exelixis and contribute to advancing patient safety in our innovative environment.
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