Aveo offers an exciting opportunity for an experienced Pharmacovigilance Director to join a rapidly growing biotech company and play an integral role in building a Pharmacovigilance infrastructure. This person will oversee clinical safety across various compounds in clinical development. This person needs to be highly motivated and is expected to provide innovative, critical, and strategic input and leadership.
The incumbent will have the following 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 requirement, such as protocols, safety summaries and regulatory reports.
- Oversee preparation and quality control activities for key safety documents (familiarity with existing safety systems such as ARISg is a plus).
- 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 trails on a global basis. Opportunity exists for direct medical monitoring of early clinical trials.
- Develop relationship with and capture drug safety info 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.
- Medical Degree (MD) or international equivalent
- At least 5 years 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
- Accredited fellowship or clinical experience in Oncology
- Clinical experience, including training, in Internal Medicine or a related specialty
- Familiarity with EU safety reporting and Eudravigilance is desirable
Aveo Oncology - 2 years ago