Senior Pharmacovigilance Lead: Signals, Reports & Strategy

Jobtailor; Cambridge (MA); On-site; USD 140,000 - 210,000; Full time

Job summary

Jobtailor is seeking a Pharmacovigilance Lead in Cambridge, MA to manage signal detection, safety reporting, and regulatory interactions. You will finalize PSURs/DSURs and mentor a safety team, collaborating with Clinical Development and Regulatory groups.

The role requires strong PV knowledge, project leadership, and data interpretation skills, with responsibility for cross-functional safety activities and regulatory liaison.

Qualifications

• Bachelor’s degree in biologic or natural science or health care discipline; advanced degree required
• Significant pharmacovigilance experience including aggregate safety reports and signal management
• Ability to interpret, analyze, and present scientific data clearly
• Experience leading projects related to signaling and regulatory agency requests
• Strong foundation in pharmacovigilance and drug development, including knowledge of safety regulations
• Proficiency in Excel, PowerPoint and Word
• Leadership and collaboration in team environments
• Knowledge of common safety database systems
• Experience interacting with cross-functional teams such as Clinical Development and Regulatory

Responsibilities

• Lead the signal management process including detection, documentation, and safety risk decisions for assigned products
• Author signal evaluation reports and manage literature reviews 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 and safety committee management
• Manage data analysis, signal detection, and product activities as assigned
• Oversee 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

Skills

Signal Detection

Safety Reporting

Data Analysis

Leadership

Project Management

Cross-functional Collaboration

Education

Bachelor’s Degree in Biologic or Natural Science

Advanced Degree (PhD, MPH, NP, PharmD)

Tools

Excel

PowerPoint

Microsoft Word

Job description

Jobtailor is seeking a Pharmacovigilance Lead in Cambridge, MA to manage signal detection, safety reporting, and regulatory interactions. You will finalize PSURs/DSURs and mentor a safety team, collaborating with Clinical Development and Regulatory groups.

The role requires strong PV knowledge, project leadership, and data interpretation skills, with responsibility for cross-functional safety activities and regulatory liaison.