You are hereJob as Pharmacovigilance Associate in AVEO Pharmaceuticals : Cambridge, MA

Job as Pharmacovigilance Associate in AVEO Pharmaceuticals : Cambridge, MA

AVEO Pharmaceuticals (NASDAQ: AVEO) integrates a proprietary cancer biology platform with drug development and commercial expertise in its efforts to discover and develop targeted cancer therapeutics. The company’s lead product, tivozanib, is an oral, triple VEGF receptor inhibitor with a highly differentiated profile. Tivozanib is currently being investigated in a global, randomized Phase 3 clinical trial called TIVO-1 comparing tivozanib to sorafenib in advanced kidney cancer, as well as additional clinical studies in other solid tumor types. AVEO’s proprietary, integrated cancer biology platform offers the company a unique advantage in oncology drug development and has provided a discovery engine for high-value targets. This approach has resulted in a promising pipeline of monoclonal antibodies against novel targets including HGF, ErbB3, RON, Notch and FGFR.

Post: Pharmacovigilance Associate : Cambridge, MA

Job Description
Relative to his or her credentials and experience, the Pharmacovigilance Associate will satisfy the various pharmacovigilance needs of AVEO—single adverse event case processing, clinical trial/protocol development and monitoring, ad hoc and aggregate safety reporting—including required regulatory documents, risk management and routine pharmacovigilance.

Directly or by oversight of safety vendors, the Pharmacovigilance Associate is responsible for components of the process of collecting, monitoring, processing, tracking and distributing of adverse event reports and information queries for investigational products. He or she is also responsible for safety and medical information for the AVEO products, including safety components of protocols and studies for assigned drugs. These activities may expand to include post-marketing activities.

Further, the incumbent will have the following responsibilities:

  • Act as an internal safety resource in connection with safety issues
  • Support other departments in safety issues, i.e. participate in the preparation of local informed consent and ‘safety-sections’ of development protocols
  • Active involvement in internal and external developments through close internal interactions and through participation in external safety meetings and assessment of external national safety information
  • Obtain and verify new information concerning pharmacovigilance
  • Support the clinical or product team in monitoring a trial, perform database reconciliation activities, and review, investigate, track, data enter, and report SAEs/AEs from clinical trials in compliance with internal and applicable global regulatory regulations governing the reporting of SAEs/AEs
  • Oversee or participate in the Drug Safety processes relating to regulatory requirements e.g. for expedited reporting and periodic safety updates, to safety surveillance for the continuous assessment of the risk profile of assigned product(s), as well as to safety methodology
  • Oversee outsourced Drug Safety processes and vendors
  • Contribute to the product strategy from a drug safety perspective
  • As appropriate, support or be responsible for Drug Safety contribution to Periodic Safety Update Reports, Patient Risk Management Plans, Investigator Brochures, Clinical Trial Reports, and Common Technical Document (Integrated Summaries of Safety) etc.
  • Advise on safety strategy for key clinical trial designs and protocols
  • As appropriate for stage of development, review published drug safety literature, published literature for reporting of single cases and identification of other important safety information for inclusion in periodic documents, issue work ups and routine monitoring activities.
  • Work with clinical operations and data management to resolve safety data collection, help maintain and update the department project calendar, and facilitate the overall efficiency of the department. Develop, maintain, and expand medical/scientific, and regulatory knowledge required to support drug safety activities
  • Assist the Pharmacovigilance Team in assessment of the overall benefit/risk of products

Candidate Profile:

  • The Pharmacovigilance Associate should possess clinical qualifications in a biomedical science, pharmacy or health sciences (MD, PharmD, RN, etc.). The candidate should possess a good understanding of normal and pathological physiological function, clinical experience appropriate to his or her credentials, and have experience with product-oriented contact with doctors and patients. Experience in academic or clinical research and/or pharmaceutical pharmacovigilance are desirable. MD with board certification in a medical subspecialty, especially in oncology or other disease areas of relative unmet medical need, would be ideal.
  • Verbal and written communication skills, detail oriented, ability to work with individuals at remote locations, and computer experience/knowledge with drug safety databases is desirable. Since the sources and spectrum of adverse drug events are large, the position demands an ability to give medical and clinical judgment, or to seek a specialist or expert advice if necessary, on a wide area of topics and therapeutic fields, both to personnel in-house, and to external clinicians and regulatory authorities

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