Medical Director Pharmacovigilance

Job Summary

A company is looking for a Medical Director Pharmacovigilance, Rare Disease & PDT.

Key Responsibilities

• Serve as Global Safety Lead and patient safety expert for assigned pharmaceutical products
• Analyze and interpret safety data to assess benefit-risk profiles and update relevant documents
• Develop strategies and lead responses to safety-related inquiries from regulatory agencies

Required Qualifications

• Doctor of Medicine (M.D.) with 5 years of related experience
• Experience with Oracle Empirica for signal detection and safety data analysis
• Knowledge of statistical methodologies for safety concern assessment
• Experience with MedDRA and WHO DD dictionary coding for adverse events
• Ability to design and implement training curriculum for Pharmacovigilance associates