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Head of Pharmacovigilance
5 months ago
DEPARTMENT: Clinical Development
DATE PREPARED: May 30, 2024
JOB SUMMARY:
The Head of Pharmacovigilance will oversee Global Safety across all AVEO marketed products and pipeline assets. This person will play an integral role in building a Pharmacovigilance infrastructure for a rapidly growing biotech company ensuring that all Pharmacovigilance functional areas are appropriately staffed, all vendor relationships run efficiently, and the Company’s global Pharmacovigilance regulatory requirements are met. A high level of motivation and engagement is expected in order to provide critical decision-making, strategic input, and leadership.
PRINCIPAL DUTIES:
The incumbent will have the following key responsibilities:
- Ensure that the full spectrum of global Pharmacovigilance activities can be carried out by AVEO in support of our marketed and to be marketed assets. Such activities include but are not limited to fulfillment of post-marketing PV requirements for Fotivda, such as case processing and reporting to Boards of Health as per regulation, aggregate reporting, signal detection and literature review. For pre-marketed assets such activities would include, expedited reporting of serious, unexpected adverse events to the Boards of Health in compliance with local regulations, and writing and submission of annual reports.
- Collaborate internally with Medical and Regulatory affairs to execute the above activities in the required timeframes.
- Provide PV staffing for each Product Development Team and coach/supervise the staff in the execution of their responsibilities to the team as they pertain to drug safety including protocol input, Investigator Brochure input, annual reports, signal detection and the key safety components of potential NDA/PMA submissions.
- Where needed to execute key activities outlined above, identify, contract with and supervise appropriate vendors in partnership with the CMO and Medical/Regulatory leadership.
- Lead periodic review of SOPs for PV and drug safety monitoring and revise or develop new SOPs where needed.
- With Regulatory Affairs, establish and oversee the implementation of the annual calendar of PV submissions and work to design the process for the generation, review, and approval of key PV documents.
- Medical Degree (MD), Doctor of Osteopathy (DO), Doctor of Pharmacy (PharmD) or international equivalent
- 10+ years’ experience in drug safety/pharmacovigilance in a pharmaceutical or biotech company, CRO or regulatory agency
- Detailed knowledge of key safety systems such as Argus
- Experience with the vendor identification and selection process for Pharmacovigilance including RFPs, bid defense, vendor auditing and due diligence, costing and contract negotiation
- Excellent verbal/written communication and presentation skills
- Ability to build relationships and influence across disciplines and all levels
- Computer proficiency including Microsoft Office applications.
- Ability to travel occasionally, as required.
- 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 is a commercial-stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA® (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology combinations in RCC and other indications, and has several other investigational programs in clinical development. AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the Company.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
