Senior Principal Scientist, Drug Safety

• Lead overall clinical risk management and safety surveillance for assigned investigational and marketed products
• Chair Risk Management Safety Teams and lead development and maintenance of risk management and pharmacovigilance plans
• Participate as a core member of Product Development Teams and related internal or joint internal/external research teams
• Partner with clinical development and Clinical Research to support robust safety assessment and benefit-risk evaluations
• Collaborate with clinical development, epidemiology, regulatory affairs, statistics, and manufacturing teams on safety topics
• Evaluate safety data from clinical trials, literature, post-approval use, aggregate data, and individual cases
• Ensure completeness of safety information in company core data sheets
• Set scientific strategy for safety-related regulatory documents, including CTD components, RMPs, and Periodic Safety Update Reports
• Ensure safety sections of company product circulars are medically and scientifically appropriate
• Conduct safety surveillance and post-approval safety signal reviews
• Collaborate with the CSRM Associate in overseeing safety surveillance activities
• Recommend pharmacovigilance actions, labeling changes, risk minimization activities, and develop RMPs and pharmacovigilance strategies
• Oversee review and approval of product labeling files in the safety database
• Prepare safety summaries and analyses for regulatory documents, aggregate reports, and regulatory filings
• May supervise CSRM medical associates performing safety analyses and authoring regulatory documents
• Participate in developing, implementing, and evaluating standards, processes, metrics, and department initiatives
Requirements
• MD, DO, or equivalent required
• Board Certification preferred
• Minimum of 3 years clinical experience following post-graduate medical training or other relevant clinical experience
• Prior experience in drug development, including clinical development and/or regulatory experience
• Experience in clinical safety, pharmacovigilance and/or risk management
• Demonstrated organizational leadership skills, preferably in the noted employment areas
• Excellent communication, writing, and analytic skills
• Knowledge of Clinical Risk Management, Clinical Safety, Data Analysis, Drug Safety Surveillance, FDA Submissions, Patient Safety, Pharmacovigilance, and Safety Reporting
• Working knowledge of MedDRA
• Oncology preferred
• US and Puerto Rico residents only
Core Competencies

Demonstrates expertise in clinical risk management, pharmacovigilance, and safety surveillance for investigational and marketed products, with a strong focus on regulatory compliance and safety data evaluation. Proven ability to lead cross-functional teams and develop comprehensive risk management strategies.
Highest-signal resume keywords
• Clinical Risk Management
• Pharmacovigilance
• Safety Surveillance
• Regulatory Experience
• Data Analysis
Hard Skills
• Clinical Safety
• Risk Management
• Drug Safety Surveillance
• FDA Submissions
• Safety Reporting
• MedDRA Knowledge
• Oncology Expertise
Soft Skills
• Organizational Leadership
• Excellent Communication
• Analytic Skills
• Writing Skills
Certifications & Qualifications
• MD
• DO
• Board Certification
Industry Keywords
• Clinical Development
• Patient Safety
• Safety Data Evaluation
• Periodic Safety Update Reports
• Risk Minimization Activities