Associate Director, Pharmacovigilance Scientist
Job Description:
• Supports Drug Safety Physician’s Safety Governance efforts by leading cross-functional Safety Management Team (SMT)
• Leads/contributes to signal detection, monitoring, evaluation, interpretation, escalation, and appropriate communication of safety information
• Maintains continuous monitoring and updates of safety profiles for assigned investigational and marketed products
• Serves as point of contact for and collaborates with colleagues from Clinical Development, Regulatory Affairs, Biostatistics, and Data Management
• Performs review of adverse event reports ensuring appropriate interpretation
• Generates or assists with input to Analysis of Similar Events
• Leads early identification of safety issues that require Safety Governance escalation
• Prepares and presents individual case safety report issues and aggregate data analyses
Requirements:
• Minimum 8+ years of Pharmacovigilance and Risk Management experience required
• Prior oncology industry experience preferred
• Experience with early phase development preferred
• Experience working in a fast-paced dynamic environment
• Prior leadership or project management experience strongly preferred
Benefits:
• 401(k) plan
• Medical insurance
• Dental insurance
• Vision insurance
• Life and disability insurances
• Flexible paid time off
• 11 paid holidays
• 80 hours of paid sick time
Apply Now
Apply Now
• Supports Drug Safety Physician’s Safety Governance efforts by leading cross-functional Safety Management Team (SMT)
• Leads/contributes to signal detection, monitoring, evaluation, interpretation, escalation, and appropriate communication of safety information
• Maintains continuous monitoring and updates of safety profiles for assigned investigational and marketed products
• Serves as point of contact for and collaborates with colleagues from Clinical Development, Regulatory Affairs, Biostatistics, and Data Management
• Performs review of adverse event reports ensuring appropriate interpretation
• Generates or assists with input to Analysis of Similar Events
• Leads early identification of safety issues that require Safety Governance escalation
• Prepares and presents individual case safety report issues and aggregate data analyses
Requirements:
• Minimum 8+ years of Pharmacovigilance and Risk Management experience required
• Prior oncology industry experience preferred
• Experience with early phase development preferred
• Experience working in a fast-paced dynamic environment
• Prior leadership or project management experience strongly preferred
Benefits:
• 401(k) plan
• Medical insurance
• Dental insurance
• Vision insurance
• Life and disability insurances
• Flexible paid time off
• 11 paid holidays
• 80 hours of paid sick time
Apply Now
Apply Now