Principal Safety Scientist

The Safety Program Manager leads high-profile safety surveillance programs, driving strategic alignment, fostering innovation, and delivering exceptional outcomes. This role involves significant stakeholder collaboration and the independent management of program portfolios

• Lead and manage assigned programs or work-verticals within the Safety Surveillance group with minimal supervision, ensuring adherence to timelines and quality standards.
• Drive key Safety Surveillance activities, including but not limited to:
  • Signal management activities.
  • Tracking and maintaining the Safety Surveillance Schedule and developing and managing Benefit-Risk Strategy Documents.
  • Leading TME query-response pathways.
  • Tracking safety communications.
  • Project managing Hepatic Assessment Committee (HAC) and managing contracts with Product Independent Experts.
  • Project managing Safety Surveillance Teams (SST), Safety Management Teams (SMT), Benefit Risk Action Teams (BRAT), Safety Monitoring Committees (SMC), and Data Monitoring Committees (DMC).
  • Contributing risk management activities and plans (RMP) and risk minimization measures (aRMMs).
• Proactively identify risks, develop mitigation strategies, and flag issues to the Head of Safety Surveillance in a timely manner.
• Partner with cross-functional stakeholders to ensure data collection, analysis, and reporting for safety activities.
• Serve as the Safety Surveillance representative in process-level audits and inspections.
• Author and critically review Quality Documents (e.g., SOPs, MIs, RTs, etc.).
• Conduct impact assessments of new regulations on safety processes and implement necessary updates
• Oversee vendor deliverables and maintain robust interaction for assigned projects
• Supports Core Trial Teams, abides to Global Program Team (GPT) framework and all applicable delivery models (e.g., Alliance, HOM, OSM, etc.).

• PhD or advanced degree in life sciences, biotechnology, pharmacy, or related fields.
• Bachelor’s degree in a relevant field with significant professional experience is also acceptable.
• Minimum 10 years of experience in pharmacovigilance, clinical safety, safety surveillance or related domains.
• Proven expertise in managing safety programs, cross-functional collaboration, and regulatory compliance.
• Experience in mentoring high-performing teams.
• Demonstrated ability to improve processes and project-manage complex, developmental products.