Senior, Clinical Safety Analyst

📋 Description

• Participates in applicable safety surveillance activities for assigned products; and in planning
• Timely assessment of adverse event coding for consistency and accuracy of coding and ; accurate and
• Supervise tracking of safety -related queries to Investigators and assists in handling safety
• Assist with Study Safety Review Plan development and implementation in collaboration with Study
• Create narratives of serious adverse events and other identified events of interest in accordance
• Apply knowledge of ICH, FDA, EMA regulations and guidelines affecting drug and disease state

🎯 Requirements

• Bachelor's degree with related health science background is required. RN or clinical pharmacy
• Minimum 3 years clinical experience with a minimum of 1 year drug safety/pharma experience (or) 2
• Proficiency in Computers (Windows, Word, Excel) and in specific databases (e.g., oracle/clinical
• Ability to critically evaluate medical data.
• Ability in accurately and medically presenting; of case data, both orally and in writing.
• Ability to identify, prioritize and assign tasks to others in Clinical Safety Manager's absence.

🎁 Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs
• Comprehensive package of benefits