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Global Pharmacovigilance Physician and Clinical Research Expert

2 weeks ago


Cambridge, Massachusetts, United States Katalyst Healthcares & Life Sciences Full time
About the Role

We are seeking an experienced Medical Director to join our team at Katalyst Healthcares & Life Sciences. As a key member of our pharmacovigilance department, you will play a crucial role in ensuring the safe use of our products worldwide.

Key Responsibilities
  • Safety Monitoring and Reporting: Develop and implement strategies for identifying and mitigating potential safety risks associated with our products, ensuring timely reporting to regulatory authorities.
  • Regulatory Compliance: Ensure compliance with all applicable regulations and guidelines related to pharmacovigilance, including GVP, ICH, and FDA requirements.
  • Collaboration and Communication: Work closely with cross-functional teams, including R&D, Clinical Operations, and Commercial, to ensure alignment on pharmacovigilance strategies and goals.
Requirements
  • Education and Experience: Doctoral degree in medicine or a related field, with a minimum of 8 years of experience in pharmacovigilance, clinical research, or clinical development.
  • Leadership and Communication Skills: Proven ability to lead and manage cross-functional teams, communicate complex ideas effectively, and build strong relationships with stakeholders.