Senior Pharmacovigilance Scientist

Responsibilities

• Lead the signal management process, including signal detection, documentation, and safety risk decisions for assigned products
• Author signal evaluation reports and manage literature review for safety information
• Respond to safety questions from regulatory authorities and lead Aggregate Report management
• Finalize aggregate safety reports such as PSURs, DSURs, REMS, and RMPs for assigned products
• Collaborate with Global Safety Officers and Safety MDs on investigational programs, including clinical trial activities and safety committee management
• Manage data analysis, signal detection, and product activities as assigned
• Oversee and spearhead critical pharmacovigilance activities as a product lead within the Safety team
• Hire, train, and mentor staff dedicated to product-specific tasks
• Ensure compliance with global safety regulations and guidelines
• Foster data analysis and product information sharing across cross-functional teams

• Bachelor’s Degree in biologic or natural science, or health care discipline; or Advanced degree (PhD, MPH, NP, PharmD, etc.) required
• Significant and proven Pharmacovigilance experience, including aggregate safety reports and safety signal management
• Ability to interpret, analyze, and present scientific and medical data clearly
• Experience leading and conducting projects related to signaling and regulatory agency requests
• Strong foundation in Pharmacovigilance and drug development, including knowledge of safety regulations
• Proficiency in common data processing software (Excel, PowerPoint, Microsoft Word)
• Leadership skills and collaborative interaction in team environments, internally and externally
• Strong organizational skills with the ability to prioritize independently
• Knowledge of common safety database systems
• Experience interacting with cross-functional teams such as Clinical Development and Regulatory

Demonstrates expertise in Pharmacovigilance, including signal management, safety report finalization, and compliance with global safety regulations. Proven ability to lead cross-functional teams and mentor staff while effectively analyzing and presenting scientific data.

• Pharmacovigilance Experience
• Aggregate Safety Reports
• Signal Management
• Leadership Skills
• Data Analysis

• Signal Detection
• Safety Risk Decisions
• Literature Review
• Safety Regulations
• Project Management
• Data Analysis
• Safety Database Systems
• Scientific Data Interpretation
• Drug Development Knowledge
• Regulatory Agency Interaction

• Organizational Skills
• Collaborative Interaction
• Mentoring
• Prioritization

• Bachelor’s Degree in Biologic or Natural Science
• Advanced Degree (PhD, MPH, NP, PharmD)

• Pharmacovigilance
• Safety Information
• Clinical Trial Activities
• Aggregate Report Management
• PSURs
• DSURs
• REMS
• RMPs
• Global Safety Officers
• Cross-Functional Teams

• Excel
• Power Point
• Microsoft Word