Director of Pharmacovigilance

3 weeks ago


Baltimore, Maryland, United States Page Mechanical Group Inc Full time

Job Summary:

Aveo Pharmaceuticals is seeking an experienced Pharmacovigilance Director to join our team and play a key role in building a Pharmacovigilance infrastructure.

This individual will oversee clinical safety across various compounds in clinical development, providing innovative, critical, and strategic input and leadership.

Key Responsibilities:

  • Provide safety and pharmacovigilance expertise in-house and by consultation with outside vendors for all development programs.
  • Be accountable for identification, assessment, and communication of potential safety signals; generate and analyze trend analysis reports.
  • Collaborate with Regulatory Affairs to ensure appropriate reporting of PV and drug safety information to regulatory agencies and prescriber community.
  • Lead development of SOPs for PV and drug safety monitoring.
  • Provide oversight and key input for review of new or on-going safety documents that ensure compliance with domestic and international regulatory requirements.
  • Oversee preparation and quality control activities for key safety documents.
  • Give key input in review and finalization of clinical protocols and other study-related documents.
  • Collaborate with a team of professionals who provide medical monitoring support for ongoing clinical trials on a global basis.
  • Develop relationships with and capture drug safety information from key groups, including partner companies, physicians, nurses, and patient advocacy groups.
  • Provide input to potential in-licensing opportunities and pharmacovigilance agreements with commercial partners.

Requirements:

  • Medical Degree (MD) or international equivalent.
  • At least 5 years of experience in drug safety/pharmacovigilance in a pharmaceutical or biotech company, CRO, or regulatory agency.
  • Excellent verbal, written, and presentation skills.
  • Ability to build relationships and influence across disciplines and all levels.


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