Medical Director, Global Patient Safety Expert

hace 1 semana

Barcelona, Barcelona, España Sin nombre A tiempo completo
Job Summary

We are seeking a highly skilled Medical Director, Global Patient Safety to join our team at Sin nombre. As a key member of our organization, you will be responsible for executing safety and risk management activities for assigned clinical development projects or marketed products.

Key Responsibilities
  1. Lead Risk Management Evaluation and Resolution: Oversee the evaluation and resolution of risks associated with assigned products and projects.
  2. Identify Potential Signals: Identify potential signals for observed adverse events and direct further review and analysis.
  3. Direct Safety Management Teams: Direct the Safety Management Team for assigned projects or products, ensuring a safety and risk/benefit driven agenda from inception to closure.
  4. Represent GPV on Project Teams: Represent GPV on other project or product teams, ensuring timely collection and processing of adverse events, assessment of suspected adverse reactions, and identification of contraindications, precautions, warnings, and other risk mitigations.
  5. Collaborate with External Resources: Collaborate with external resources such as Clinical Operations and Clinical Scientist on the identification of and resolution for potential signals.
  6. Detect and Manage Safety Signals: Detect, validate, and manage pre- and/or post-approval safety signals through to resolution.
  7. Ensure Timely Recording of Risk Management Action Plans: Ensure timely, accurate recording of risk management action plans and decisions.
  8. Conduct Medical Assessment of Causality: Conduct medical assessment of causality of Individual Case Safety Report (ICSR) as necessary.
  9. Evaluate Aggregate Safety Data: Evaluate aggregate safety data and write contributions to its interpretation for various safety and risk/benefit evaluations.
  10. Provide Medical Interpretation of Complex Data: Provide medical interpretation of complex PV and pharmacoepidemiological data to enable clinical and regulatory decision-making.
  11. Identify and Manage Labeling Updates: Identify, initiate, and manage necessary updates to labeling documentation.
  12. Conduct Medical Evaluation of PV Operations Issues: Conduct medical evaluation of issues arising from PV Operations.
  13. Provide Medical Input to ARGUS Search Criteria: Provide medical input to ARGUS search criteria as necessary.
Requirements
  1. MD Required: Must have a medical degree.
  2. Five Years of Safety and Risk Management Experience: Five years of relevant safety and risk management experience in the pharmaceutical industry.
  3. Knowledge of PV Deliverables, Standards, and Processes: Knowledge and understanding of PV deliverables, standards, and processes.
  4. Broad and Deep Knowledge of Drug-Induced Disease: Broad and deep knowledge of the principles, concepts, and theories of drug-induced disease for therapeutic/product area(s).
  5. Excellent Judgment and Communication Skills: Excellent, independent judgment based on leading-edge knowledge and expertise, and strong verbal and written communication skills.
  6. Problem-Solving Skills: Sound problem-solving skills including the ability to make decisions by developing innovative options and/or multiple solutions to highly complex problems.
  7. Ability to Manage Multiple Tasks: Ability to manage multiple overlapping complex tasks to conclusion, sometimes to tight timelines.
Preferred Qualifications
  1. 4+ Years in Clinical Medicine: Four or more years in clinical medicine (post-training/residency).
  2. Rare, Ultra-Rare, or Orphan Disease Area Experience: Experience in rare, ultra-rare, or orphan disease areas.
  3. Strong Time-Management and Project-Management Skills: Strong personal time-management and project-management skills.
  4. Collaborative Skills: Collaborative skills to partner with internal and external teams.

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