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 #J-18808-Ljbffr Jobtailor