Director of Pharmacovigilance
3 weeks ago
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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