Global Medical Director

hace 7 días


Barcelona, Barcelona, España Sin Nombre A tiempo completo

Job Summary

Sin Nombre is seeking a highly skilled and experienced Medical Director to lead our Global Patient Safety and Risk Management efforts. As a key member of our team, you will be responsible for executing safety and risk management activities for our clinical development projects and marketed products.

Key Responsibilities

  • Lead risk management evaluation and resolution for assigned products and projects
  • Identify potential signals for observed adverse events for further review and analysis
  • Direct the Safety Management Team for the assigned project(s) or product(s), ensuring a safety and risk/benefit driven agenda from inception to closure
  • Represent GPV on other project/product team(s) or subteam(s), ensuring processes for timely collection and processing of adverse events, assessment of suspected adverse reactions, and identification of contraindications, precautions, warnings, and other risk mitigations
  • Collaborate with external resources such as Clinical Operations and Clinical Scientist on the identification of and resolution for potential signals
  • Detect, validate, and manage pre- and/or post-approval safety signals through to resolution
  • Ensure timely, accurate recording of risk management action plans and decisions
  • Conduct medical assessment of causality of Individual Case Safety Report (ICSR) as necessary
  • Evaluate aggregate safety data and write contributions to its interpretation for various safety and risk/benefit evaluations
  • Provide medical interpretation of complex PV and pharmacoepidemiological data to enable clinical and regulatory decision-making
  • Identify, initiate, and manage necessary updates to labeling documentation
  • Conduct medical evaluation of issues arising from PV Operations
  • Provide medical input to ARGUS search criteria as necessary

Requirements

  • MD Required
  • Five years relevant safety and risk management experience in the pharmaceutical industry
  • Knowledge and understanding of PV deliverables, standards, and processes
  • Broad and deep knowledge of the principles, concepts, and theories of drug-induced disease for therapeutic/product area(s)
  • Excellent, independent judgment based on leading-edge knowledge and expertise
  • Strong verbal and written communication skills


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