Senior Pharmacovigilance Scientist

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

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

Requirements

• 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

Core Competencies

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.

Highest-signal resume keywords

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

ATS Optimization Keywords

Hard Skills

• 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

Soft Skills

• Organizational Skills
• Collaborative Interaction
• Mentoring
• Prioritization

Certifications & Qualifications

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

Industry Keywords

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

Tools & Technologies

• Excel
• PowerPoint
• Microsoft Word