Antigenics is working to develop personalized immunotherapeutics and revolutionary treatments
for cancers, infectious diseases and autoimmune disorders. The company's lead product
candidate is Oncophage, a late-stage, personalized cancer vaccine being evaluated in several
indications, including kidney cancer and metastatic melanoma. Antigenics' portfolio also
includes AG-858, a personalized cancer vaccine in Phase II development; Aroplatin and ATRA-IV,
two Phase II liposomal chemotherapeutics; and AG-702/AG-70X, a Phase I genital herpes
This position assures the timely and accurate collection, review and analysis of Serious
Adverse Events, Safety data for Annual Reports, DMC meetings, SAE Reconciliation, and
Investigator’s Brochures (foreign and domestic). Produces Serious Adverse Event reports – all
products and indications – US and international. The Manager will oversee implementation
production and maintenance of Pharmacovigilance system (Clintrace); Provides Clinical Safety
expertise to staff, protocols, and CRF design as well as SAE reconciliation for all ongoing
studies. Manage timelines/resource allocations for in-house Pharmacovigilance activities.
Develop and implement Pharmacovigilance Standard Operating Procedures (SOP) and best
practices. Define and monitor key performance metrics and be the liaison with Medical,
Biometrics, Clinical, IT, Data Management, Vendors, and Corporate. Update Annual Reports and
Investigator’s Brochure with appropriate safety summaries and narratives. Provide direction
and oversight to CROs for Drug Safety and SAE reconciliation. Manage, train, and measure the
performance and development of Pharmacovigilance staff and activities.
Qualifications: BS/MS, or BA or a degree or equivalent in scientific or health care field
preferred; 5-7 years of related experience; 2-3 years of management experience. Excellent oral
and written communications and organization skills are essential. Demonstrated ability to lead,
prioritize, problem solve and work within a matrix team environment required.