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Posted: Thursday, August 17, 2017 7:45 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 support Provide administrative support to the US Regional Pharmacovigilance Department Provide excellent customer service to department employees internal stakeholders customers and business partners Schedule and cancel appointments as requested Prepare department meeting agenda send notification for department meetings record and maintain meeting minutes Generate schedule and track report requests Maintain department files and records Other daily administrative tasks including email maintenance appointment reminders meeting invitations and associated logistical support Pharmacovigilance Related tasks Demonstrate flexibility and ability to prioritize multiple projects involving potentially high volume of time sensitive reports daily Demonstrate ability to organize and track assignments deliverables and job related activities with moderate oversight Assist 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 audits Assist 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 activities Assist with SOP management training record filing and tracking office expense and reports as applicable Drug Safety Mailbox Monitor and maintain US PV departmental Drug Safety Mailbox each day Review 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 day Aggregate Report Schedule Manage 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 contributors Ensure PADERs are compiled on a timely basis PADER Notifications Responsible for sending PADER Notifications to internal stakeholders Collaborate with Regulatory affairs Medical writing Clinical Operations and other stake holders on PADER and Periodic Safety Update Report PSUR Notifications PADER Review and Submission Responsible for generating and reviewing Aggregate report Line listings PADER Author Zero Case PADERs and PADER Cover letter to FDA Request eCTD Submission sequence numbers H form and PADER reports from internal stake holders Responsible for review and submission of Aggregate report to FDA Education Associates degree with to years of relevant experience or BS BA with to years of relevant experience Health Care Professional preferred Experience 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 skills Good understanding of medical terminology and clinical information Bilingual English Spanish a plus EOE MF Vet Disabled


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