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Safety Aggregate Reporting Specialist 2 (Home-based)

Company: IQVIA
Location: Durham
Posted on: September 11, 2020

Job Description:

JOB OVERVIEW:Apply knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents.ESSENTIAL FUNCTIONS:Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA).Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required.Conduct/Lead ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review.Act as Signal Management Lead on post-marketing and clinical trial projects. Set-up, implement, organize (including documentation) and lead safety management teams. Set-up and update products' signaling strategies. Author and/or QC review all types of signal management deliverables. Lead/ conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks . Responsible for full documentation and tracking of a PV support role, lead/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling terface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory affairs Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), -and Information Technology (IT), as needed.Participate in internal and external audits and inspections, as required.Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics.Read, acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented.Serve as the interface between the global project lead and the working teamConduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members.Provide mentorship and training to less experienced resources.Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concernsParticipate in project review meetings with managementCommunicate and document project issues to project team members and department management in a timely manner. Ensure Good Documentation Practices (GDP).Support and/or contribute to technology / innovation activities.QUALIFICATIONS:Excellent knowledge of Lifecycle Safety services and processes.Willingness and aptitude to learn new skills across Lifecycle Safety service depth knowledge and understanding of applicable global, regional, local regulatory requirements i.e. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and International Conference of Harmonization (ICH) guidelines, SOPs.Proven ability to meet strict deadlines.Manage competing priorities and ability to be flexible and receptive to changing demands.Excellent organizational skills and time management skills.Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint).Good knowledge of medical terminology.Proven ability to follow instructions/guidelines, work independently and on own initiative.Excellent attention to detail and accuracy maintaining consistently high quality standards.Excellent written/verbal communication and report writing skills.Sound judgment, independent thinking, and decision making skills.Self-motivated and flexible.Ability to establish and maintain effective working relationships with coworkers, managers and clients.Effective mentoring and coaching skills.Good understanding of operational metrics, productivity and initiatives.Demonstrate effective project management and leadership skills.EDUCATION & EXPERIENCE: --- Bachelor's Degree required with 2 - 3 years relevant work experience OR equivalent combination of education, training and experience.At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at .IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/DisabledIQVIA, Inc. provides reasonable accommodations for applicants with disabilities. -Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA's Talent Acquisition team at workday_recruiting@ to arrange for such an accommodation.Full time

Keywords: IQVIA, Durham , Safety Aggregate Reporting Specialist 2 (Home-based), Advertising , Durham, North Carolina

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