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Posted: Friday, August 18, 2017 8:20 AM

The Pharmacovigilance Coordinator will support the US and Regional Pharmacovigilance team. He or she will provide administrative and logistical support with adverse event (AE) case management, production of aggregate safety reports, and other pharmacovigilance related activities as assigned. The PV coordinator will also assist with regulatory safety reporting, queries, data listings and reconciliation, in accordance with the company Standard Operating Procedures and applicable International Conference on Harmonization (ICH) / Good Clinical Practice (GCP) guidelines. This individual will also assist in maintaining accurate and audit-ready files, and assist with various other department administrative needs, including meeting scheduling, room reservation, note taking, and employee on-boarding. This role will require a detail oriented nature as well as excellent project management skills. Additionally, this individual will interact with PV Managers and personnel, regional affiliates, third- party vendors, and assist with any PV related tasks including monitoring drug safety mailbox on a daily basis and assist with various other department administrative needs.Administrative supportProvide administrative support to the US & Regional Pharmacovigilance DepartmentProvide excellent customer service to department employees, internal stakeholders, customers, and business partnersSchedule and cancel appointments as requested.Prepare department meeting agenda, send notification for department meetings, record and maintain meeting minutesGenerate, schedule, and track report requests.Maintain department files and recordsOther daily administrative tasks including email maintenance, appointment reminders, meeting invitations and associated logistical supportPharmacovigilance Related tasksDemonstrate flexibility and ability to prioritize multiple projects, involving potentially high volume of time sensitive reports dailyDemonstrate ability to organize and track assignments, deliverables, and job-related activities with moderate oversightAssist with preparing for periodic internal reviews of safety systems, files, and study related documentation of all safety related projects in preparation for agency or sponsor auditsAssist with project archival activities, including inventory, CD burning, and shipping as required.Assist with office supply management, general office tasks, and visitor or group meeting coordination and preparation activitiesAssist with SOP management, training record filing and tracking, office expense and reports as applicableDrug Safety MailboxMonitor and maintain US PV departmental Drug Safety Mailbox each dayReview all incoming email and archive appropriately to the assigned folders to clear out the mailbox with no pending email at the end of each business dayAggregate Report ScheduleManage and maintain the USA aggregate report schedule (Periodic Adverse Drug Experience Reports - PADERs)Update PADER Schedule with new Product Approvals as received from Regulatory Affairs. Track and follow up with contributorsEnsure PADERs are compiled on a timely basisPADER NotificationsResponsible for sending PADER Notifications to internal stakeholdersCollaborate with Regulatory affairs, Medical writing, Clinical Operations and other stake holders on PADER, and Periodic Safety Update Report (PSUR) NotificationsPADER Review and SubmissionResponsible for generating and reviewing Aggregate report Line listings (PADER) Author Zero Case PADERs and PADER Cover letter to FDARequest eCTD Submission sequence numbers, 356 H form and PADER reports from internal stake holdersResponsible for review and submission of Aggregate report to FDAEducationAssociates degree with 2 to 3 years of relevant experience or BS/BA with 1 to 2 years of relevant experience Health Care Professional preferredExperience1-3 years of relevant experience as a PV Coordinator and daily operational duties of Aggregate Reports preferred Excellent attention to detail and effective organizational skills Knowledge and Skills Quality oriented, with attention to detail/accuracy, and ability to manage multiple and varied tasks and prioritize workload Knowledge of Microsoft Office (Word, Excel & PowerPoint)Excellent interpersonal and communication skillsGood understanding of medical terminology and clinical information Bilingual English/Spanish, a plusEOE/M/F/Vet/Disabled


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