Principal Pharmacovigilance Specialist, CaseProcessing - 12 Month FTCThe Principal Pharmacovigilance (PV)Specialist, Case Processing is primarily responsible fordirectional leadership of PV clients that are contracted for anextensive suite of PV services while collaborating with ClientServices on standard service offerings. The Principal PV Specialistserves as a subject matter expert of PV to assist in creatingrelated project documents and guidance as needed. The Principal PVSpecialist, Case Processing acts with limited oversight and abilityto research, implement and manage PV services as contracted orrequested; is responsible for maintaining a working knowledge ofGlobal PV requirements for marketed products; and ensurescompliance with all applicable regulations and internal SOPs. ThePrincipal PV Specialist also assists the team with peer review anddata entry as needed.Essential Functions:Provide oversight anddirection as a PV subject matter expert, enhancing client serviceinternally and externally.Oversee the development of detailedproject/program specific, Working Practices, Work Instructions, andother documents as applicable (e.g., Safety Data Exchange or PVAgreements).Serve as a resource for Case Processing team forcomplex cases and escalated inquiries.Perform case follow upactivities such as identification of information to be collectedduring follow-up.Creating and reviewing case narratives.Providingclient notifications as required for case management.Supporting andcontributing to the development of training materials and trainingdelivery.Highlight areas of concern/discrepancies to the PrincipalPV Specialist, Case Processing and/or Manager, Case Processing whenrelated to ICSRs.Acquire and maintain an up-to-date knowledge ofglobal safety regulations for medicines.Peer reviews of cases forquality, consistency, and accuracy as needed.Perform Health CareProfessional (HCP) review (as required).Mentors and trains lessexperienced staff.Other duties as assigned.Necessary Skills andAbilities:Strong verbal, written and interpersonal communicationskills with clients, external and internal staff. Excellent projectmanagement skills.High level of accuracy and attention to detail.Advanced problem-solving skills and ability to resolve problems ina timely manner. Able to work independently and collaboratively ina multidisciplinary team. Excellent organization and prioritizationskills with attention to detail. Advanced Knowledge ofPharmacovigilance.Advanced knowledge of PV Systems, such as OracleArgus Safety, ARISg, or other safety databases. Self-motivated tomaintain high efficiency and productivity levels and managemultiple projects and clients. Educational Requirements:Required: aBachelors degree in life sciences.Preferred: an advanced degree,RN, RPh, PharmD or equivalent. Experience Requirements:Four yearsof related work experience.