Senior Medical Safety Scientist

Education/Experience/Skills

• PharmD, PhD, MS, MSN, MPH, RN, NP, PA, or equivalent degree from an accredited institution
• 7+ years of experience in drug safety, pharmacovigilance, clinical safety, or risk management within the pharmaceutical or biotechnology industry
• Experience in safety surveillance, signal detection and management, aggregate safety data review, benefit-risk assessment, and product safety evaluation
• Experience authoring regulatory safety documents including signal assessments, DSURs, PBRERs, safety sections of clinical documents, aggregate reports, and health authority responses
• Advanced knowledge of FDA, EU, and ICH regulations and guidelines related to pharmacovigilance, clinical trial safety monitoring, signal management, aggregate reporting, and post-marketing surveillance
• Expertise in safety signal detection, validation, evaluation, and risk assessment methodologies
• Experience with pharmacovigilance databases and safety systems, including Argus Safety, as well as signal detection tools
• Strong knowledge of MedDRA coding conventions, safety data review methodologies, and adverse event analysis
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
• Ability to travel domestically and internationally as required

• Serve as the scientific safety lead for assigned products, providing pharmacovigilance expertise across clinical development and post-marketing activities
• Conduct routine and ad hoc review of safety data from clinical trials, post-marketing sources, literature, business partners, and other relevant sources to support ongoing safety surveillance
• Lead signal detection, validation, evaluation, tracking, and aggregate safety analyses, including review of case series, adverse event trends, data mining outputs, and benefit-risk assessments
• Author and maintain key safety deliverables including signal assessments, safety evaluations, benefit-risk assessments, safety narratives, AOSEs, Safety Surveillance Plans (SSPs), and signal management documentation
• Support aggregate safety reports, regulatory submissions, health authority responses, core safety information, Risk Management Plans (RMPs), REMS activities, and other product risk management initiatives
• Provide scientific safety expertise to governance committees and cross-functional teams, including Clinical Development, Regulatory Affairs, Biostatistics, Medical Writing, Epidemiology, Medical Affairs, and Quality
• Review safety listings, line listings, adverse event summaries, and retrospective safety data analyses to identify and evaluate emerging safety concerns and risks
• Support audits, inspections, and regulatory authority inspections by ensuring safety documentation is accurate, complete, and inspection ready while maintaining compliance with global pharmacovigilance regulations and Good Pharmacovigilance Practices (GVP)
• Maintain current knowledge of safety science methodologies, signal management practices, and evolving global regulatory requirements
• Other duties as assigned