Safety Aggreg Report Spec 2

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 signals In a PV support role lead author and or QC review safety responses to regulatory agencies PRAC and justification documents to support labelling documents Interface 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 team conduct 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 concerns participate in project review meetings with management communicate 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 Generates analyzes and summarizes aggregate safety data to discern new signals and as required commences benefit-risk evaluation and determines risk-mitigating activity Collaborates with client and regulatory stakeholders and internal project teams to determine the safety analysis required performs the search for applicable safety data aggregates analyzes and archives the safety data completes templates for reporting and evaluating signals or benefit-risk analysis and publishes and submits aggregate safety reports to regulatory bodies on behalf of contracted clients and corresponds with regulatory bodies as required Qualifications Bachelor s Degree In a Scientific or Healthcare discipline Req 3 - 4 years relevant work experience Pref Equivalent combination of education training and experience Req Excellent knowledge of Lifecycle Safety services and processes Intermediate willingness and aptitude to learn new skills across Lifecycle Safety service lines Advanced In depth knowledge and understanding of applicable global regional local regulatory requirements Intermediate i e Good Clinical Practice GCP Good Pharmacovigilance Practice GVP and International Conference of Harmonization ICH guidelines SOPs Intermediate Proven ability to meet strict deadlines Advanced manage competing priorities and ability to be flexible and receptive to changing demands Intermediate Excellent organizational skills and time management skills Intermediate Good working knowledge of Microsoft Office and web-based applications e g Word Excel Powerpoint Intermediate Good knowledge of medical terminology Intermediate Proven ability to follow instructions guidelines work independently and on own initiative Intermediate Excellent attention to detail and accuracy maintaining consistently high quality standards Advanced Excellent written verbal communication and report writing skills Intermediate Sound judgment Intermediate independent thinking and decision making skills Intermediate Self-motivated and flexible Advanced Ability to establish and maintain effective working relationships with coworkers managers and clients Intermediate Effective mentoring and coaching skills Intermediate Good understanding of operational metrics productivity and initiatives Intermediate Demonstrate effective project management and leadership skills Intermediate IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide Learn more at