Job type contract
Full job description
Pharmacovigilance systems lead- contract to hire - remote
The pharmacovigilance systems lead is responsible for managing pharmacovigilance (pv) systems oversight of argus safety related changes, as well as associated argus safety reports and projects within a dedicated safety database environment.
Essential functions include:
Manage and approve daily argus configuration changes as the database controller via the argus safety change management standard operating procedures (sop).
Attend and/or lead the client argus safety governance committee (asgc) meeting as a (pv) director delegate to provide oversight and guidance on changes, argus projects and ongoing issuesResponsible pv systems person for dedicated client safety database.
Attend all meetings as a pv systems subject matter expert (sme).
Participate in and contribute to safety system design requirement specifications for the safety database as a pv systems smeManage conference room pilots; review changes and validation activitiesProvide vendor oversight of report development: compliance, aggregate, signal detection, data mining, key performance indicators (kpis)Establish, monitor, and report on service level kpisDevelop, update, and maintain dedicated work instructions for global service desk requests, change plan development, approval and closureDevelop, update, and maintain dedicated templates (including team member training) on tenant configuration, business configurations, code list changes, and user permissionsDevelop, update, and maintain dedicated work instructions associated with ongoing safety database maintenance projects, including upgrades, medical dictionary for regulatory activities (meddra) / whodrug versioning, direct electronic submission gateway (esg) setup, etcPrimary lead for deliverables and participate in audits and inspections of the dedicated pv system.
Required: bachelor’s degree or equivalent.
Required: business analyst, pharmacist (rph), nurse (rn) or equivalent.
Required: 5 years of experience as a user and/or administrative role within a pharmacovigilance safety databaseRequired: 3 years of experience as a user and/or administrative role within argus safetyRequired: 1 year of experience executing and/or managing pharmacovigilance database configuration changesPreferred: 1 year of experience executing and/or managing argus safety configuration changesRequired: working knowledge and understanding of pharmacovigilance regulations and guidance documentation to facilitate industry best practice.
Proficient computer knowledge and keyboarding skills including intermediate proficiency with microsoft office (outlook, word, excel)Advanced working knowledge of argus safety databaseWorking knowledge and understanding of the legal and regulatory environment within pharmaceutical industry to facilitate industry best practiceExceptional organization, prioritization, project management skills; with strong attention to detailExcellent written, verbal and interpersonal communication skills with ability to establish strong professional relationships with argus safety it service partner, internal staff and dedicated clientStrong verbal skills to lead meetings with internal staff, argus safety it service partner and dedicated clientExceptional customer service skillsStrong critical thinking and problem-solving skills.
Flexibility to adapt and meet fluctuating business prioritiesExcellent internal and external customer service skills.
Bhavani apexon mobile : +1 248 952 7037 firstname.lastname@example.org
Posted 30+ days ago