(Only 24h Left) Safety Aggreg Report Manager

Job Overview Act as a stand-alone global functional lead at a project level applying experience knowledge and expertise for Safety Aggregate Report and Analytics SARA Center deliverables including but not limited to safety aggregate reports literature surveillance signal management activities and benefit risk management documents Actively contribute to Lifecycle Safety global process initiatives and work in close collaboration with the safety customer delivery management team regarding project client initiatives Ensure team is following standard best-in-class practices established by the SARA infrastructure Essential Functions Serve as a stand-alone global lead for aggregate reporting signal management or literature survellance projects Lead author and finalize aggregate reports including but not limited to PBRERs PSURs DSURs PADERs RMPs REMS ACOs line listings and author responses to regulatory agency Pharmacovigilance Risk Assessment Committee PRAC inquiries as required Act as literature lead back-up lead reviewer QCers to conduct 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 or signal detection relevance review Author and or contribute to literature deliverables for aggregate reports or signal management activities meeting strict regulatory timelines Act as Signal Management Lead on large and or complex post-marketing and clinical trial projects Set-up implement organize including documentation and lead safety management teams Serve as subject matter expert across projects for complex data mining methodogies and algorithms on internal and external safety datasources Oversee set-up and update products signaling strategies Oversee author and or QC review all types of signal management deliverables Oversee 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 Accountable for full documentation and tracking of signals At project level maintain compliance prepare metrics and KPI present at audits and inspections In a PV support role act as functional lead and oversee author and or QC review safety responses to regulatory agencies PRAC and justification documents to support labelling documents Provide training to SARA staff for qualification on SARA deliverables May perform quality check of all assigned SARA deliverables be responsible for the quality of the final SARA deliverable to client regulatory IQVIA regulatory reporting RR and regulatory authorties Provide consultative guidance to internal and external stakeholders in the for all SARA deliverables Act as mentor to and coach to project team staff and direct line reports 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 Business development BD and Proposals and Information Technology IT as needed Participate in internal and external audits as required Lead audit preparation activities in advance to audit and ensure audit readiness of project Review project files and contact lists on a regular basis to ensure compliance with SOPs Lead functional team and contribute to achievement of departmental goals e g utilization realization and productivity metrics Read and acknowledge all necessary IQVIA standard operating procedures SOPs and customer SOPs as required Ensure all required training is executed in a timely fashion and documented Ensure Good Documentation Practices GDP Serve as the interface between the global project lead and the working team conduct regular lessons learnt 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 statement of work 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 Contribute to resource needs and resource allocation based on workload to ensure appropriate compliance with report submissions Build a positive collaborative team environment with SARA team members lead by example and provide training and mentoring for local project leads and less experienced team members Contribute and assist in global local working groups as applicable in implementation of new operational initiatives identification and implementation of process efficiencies Participate in the review of existing standard operating procedures SOPs Proactively identify issues and propose solutions Provide consultative guidance to internal and external stakeholders for all SARA deliverables Suggest drive and implement continuous process improvements across all SARA center services Collaborate with line managers to resolve project performance related issues of staff Qualifications Bachelor s Degree in a Scientific or Healthcare discipline Req 4 - 6 years relevant work experience pref Equivalent combination of education training and experience Req Extensive knowledge of Lifecycle Safety processes audit practices governing safety legislation regulation Advanced willingness to increase knowledge across IQVIA Safety service lines and develop new skills Advanced Extensive knowledge of applicable global regional local regulatory requirements Advanced i e Good Clinical Practice GCP Good Pharmacovigilance Practice GVP and International Conference of Harmonization ICH guidelines SOPs Advanced Proven ability to meet strict deadlines Advanced manage competing priorities and ability to be flexible and receptive to changing demands Advanced Strong organizational and time management skills Advanced Proven ability to follow instructions guidelines work independently and own initiative s Advanced Excellent attention to detail and accuracy maintaining consistently high quality standards Advanced Excellent written verbal communication and report writing skills Advanced Ability to establish and maintain effective working relationships with coworkers managers and clients Advanced Excellent understanding of operational metrics productivity and initiatives Advanced Excellent project management leadership and mentoring skills Advanced Excellent presentation and customer-focused skills Advanced Excellent judgment decision-making and problem solving skills Advanced Encourage a flexible and receptive approach to changing demands and proven ability in the implementation of new initiatives Advanced 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