Senior Medical Director Safety & Pharmacovigilance
SciPro - United States
Hiring: Senior Medical Director Safety & Pharmacovigilance Company: SciPro Location: United States Job Posted Time: 2026-09-16 15:24:20 Employment Type: Remote Target Skills & Keywords : Regulatory Compliance About the job Experience: •5 years of experience in Drug Safety or Pharmacovigilance, including medical review of ICSRs. Required Skills: •Conduct medical review of Individual Case Safety Reports (ICSRs), including evaluation of case narratives, medical assessments, expectedness, and causality. •Provide medical expertise on complex, serious, and medically significant adverse event cases. •Support signal detection and ongoing safety surveillance activities through the review and interpretation of aggregate safety data. •Present and discuss safety findings in cross-functional safety governance meetings and review forums. •Perform quality review of safety data and ensure compliance with global pharmacovigilance regulations and reporting requirements. •Partner with Clinical Development, Regulatory Affairs, and other internal stakeholders to provide medical input on safety-related topics, including study protocols and investigator-facing documents. •Contribute to the development, maintenance, and continuous improvement of pharmacovigilance processes and documentation. •Interact with clinical investigators and external partners to obtain additional medical information and case follow-up as needed. Qualifications: •MD, DO, or equivalent medical degree required. •Minimum of 5 years of experience in Drug Safety or Pharmacovigilance, including medical review of ICSRs. •Strong clinical judgment with demonstrated experience assessing causality, expectedness, and the medical significance of adverse events. •Prior experience supporting post-marketing safety activities preferred. •In-depth knowledge of global pharmacovigilance regulations, safety reporting requirements, and industry best practices. •Excellent communication, analytical, and problem-solving skills. Compensation: •Flexible work environment (work from home / hybrid options) Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!