Senior Medical Director - Pharmacovigilance

Employment Type: Full-time Work Schedule: Standard (Mon-Fri) Environmental Conditions: Office Location Type: Fully Remote (United States) Travel: 10-20% (international may be required)

Position Overview

At Thermo Fisher Scientific, we are seeking a highly motivated and experienced Senior Medical Director to join our world-class organization. This role offers the opportunity to engage in meaningful work that positively impacts global health. You will be instrumental in enabling our customers to make the world healthier, cleaner, and safer by providing critical expertise within our Pharmacovigilance (PV) physician team. This position is fully remote, benefit-eligible, with a travel requirement of 10-20%.

Responsibilities

• Leadership and Strategy:
  • Assume advanced leadership responsibilities within the PV physician team, potentially including direct line management.
  • Act as the primary point of contact between the PV physician group and other PV leaders.
  • Provide leadership and strategy to multidisciplinary teams within PV and across the company, focusing on operations, training, business objectives, quality, process improvement, compliance, and innovation.
  • Apply therapeutic area expertise and indication-specific knowledge to offer medical consultation, strategic direction, and risk mitigation strategies to internal teams and clients.
  • Support business development activities.
  • Manage, mentor, and oversee PV physicians globally, supporting training and end-to-end medical monitor and/or safety physician activities across the pharmaceutical product lifecycle.
  • Foster a culture of accountability and continuous process improvement.
  • Develop and manage resource allocation plans and budgets.
• Client and Departmental Liaison:
  • Serve as the PV physician team liaison with other PPD departments and clients.
• Medical Review and Analysis:
  • May provide oversight of medical review and analysis of data for:
    • Clinical trial serious adverse events.
    • Aggregate reviews (e.g., trending and listings).
    • Marketed products ICSR and periodic safety reports (e.g., PBRER, PSUR, DSUR).
    • Other client deliverables (e.g., labeling reconciliation documents, CTD modules, REMS, RMP, signal detection reports, CSR).
• Global and Regional Medical Leadership:
  • Provide global and regional medical leadership, mentoring, and oversight to direct reports (if applicable) and the global PV physician team.
  • Serve as a consultant and spokesperson for the PV physician team or the PV organization on significant matters.
• Clinical and Pharmacovigilance Expertise:
  • Utilize subject matter clinical and pharmacovigilance expertise, combined with product or therapeutic area knowledge, for:
    • Interpretation of safety and efficacy data.
    • Therapeutic and protocol training.
    • Identification and evaluation of safety signals.
    • Driving decision-making on risk/benefit evaluation and argumentation.
    • Pharmaco-epidemiological or clinical trial data interpretation.
    • Risk assessment (if applicable).
• Collaboration and Process Improvement:
  • Create formal networks with key decision-makers.
  • Collaborate with cross-functional group leaders to develop, promote, and contribute to strategic process improvement initiatives and planning of training and development programs.
• Quality and Compliance:
  • Serve as the primary point of contact for activities related to quality and reporting compliance of safety reports.
  • Act as a subject matter expert for these topics during audits and inspections.

Company Information

At Thermo Fisher Scientific, we are dedicated to enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while advancing science through research, development, and the delivery of life-changing therapies. With clinical trials conducted in over 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital, and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.