Internship: Patient Safety and Pharmacovigilance

What You’ll Do:

The Patient Safety and Pharmacovigilance Intern (PSPV Intern) will report directly to the Senior Director, PV Operations and will work with PSPV and cross-functionally. This individual will be responsible for assisting members of the PSPV team with a variety of day-to-day tasks and support key PSPV projects/initiatives including safety vendor management, safety database oversight, ICSR review, signal detection and literature assessments, support projects, and participate in team activities.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Research and understand the disease, symptoms, and treatment under investigation
• Participate in safety data analysis/signal detection (ICSR and aggregate data review)
• Understand the process of vendor management
• Review applicable Health Authority regulations and ICH guidelines to develop working knowledge of PSPV reporting obligations to ensure patient safety
• Lead a defined project (e.g. process optimization, data visualization, or data analytics) and prepare a final presentation for department and company leadership
• Opportunity to support PSPV projects

Required Qualifications:

• Proactive, engaged, eager and willing to learn approach to work
• Support and be part of the Kailera core values: Courageous, Collaborative, Compassionate, and Committed
• Excellent oral and written communication skills
• Interest and/or experience in drug safety and pharmacovigilance a plus
• Ability to work well in a fast-paced team environment

Education:

• Bachelor’s degree candidates who have completed two or more years and are pursuing a degree in life sciences (nursing, neuroscience, psychology, psychiatry, biology, pharmacy