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Principal Safety Scientist

  1. India
2025-119349
  1. ICON Strategic Solutions
  2. Other
  3. Office Based

About the role

This vacancy has now expired. Please click here to view live vacancies.

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.
List #1

Day in the life

From Clinical Trial Assistant to Clinical Operations Manager

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A Day In The Life

Content type

Blogs

Publish date

04/21/2023

Summary

From Clinical Trial Assistant to Clinical Operations Manager, Adrienne Purdy shares her journey.Tell us about you role and what you do at ICON?  I have been at ICON since 2013 and I have been growing

Teaser label

Adrienne Purdy shares her career journey and experience at ICON.

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Adrienne Purdy

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Adrienne Purdy

Adrienne Purdy

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