Scientific Director – SERM, Clinical Safety, Pharmacovigilance

• Lead safety review and risk management activities for assigned products
• Evaluate safety data from clinical trials, post-marketing sources, and scientific literature
• Support global regulatory submissions and health authority interactions
• Draft and review responses to Health Authority Requests for Information (RFIs)
• Provide protocol, safety, and regulatory support to clinical development teams
• Participate in cross-functional safety governance and risk management activities
• Identify emerging safety concerns and recommend appropriate actions
• Collaborate with internal stakeholders to ensure scientifically sound and compliant safety strategies
• Provide scientific leadership in product safety evaluation, benefit-risk management, and pharmacovigilance across clinical development and post-marketing programs
• Independently manage safety issues and contribute to strategic safety decision-making across global programs

• Advanced scientific or healthcare-related degree (PhD, PharmD, MS, NP, RN, or equivalent)
• Significant experience in clinical development, drug safety, pharmacovigilance, or a related field
• Experience responding to Health Authority Requests for Information (RFIs)
• Strong protocol support and regulatory experience
• Excellent analytical, scientific writing, and communication skills
• Proficiency in English is mandatory
• Ability to work independently and appropriately escalate issues when needed
• Experience working effectively within global cross-functional teams
• Oncology experience is highly desirable but not required
• Experience interacting with FDA, EMA, PMDA, and other global regulatory agencies
• Experience supporting global development programs
• Availability to work within U.S. and/or U.K. business time zones

• 1-Year Contract with potential extension
• Remote work arrangement based in Brazil