Safety Aggregate Report Manager

IQVIA; Bengaluru; On-site; INR 2,400,000 - 4,200,000; Full time

Job summary

IQVIA is seeking a Senior Safety Aggregation Reporting Manager to act as a standalone global lead for SAF aggregate reporting and analytics, coordinating with cross-functional teams to deliver PBRERs/PSURs and related literature surveillance. You will manage signal management activities, data mining methodologies, and regulatory responses while ensuring GDP and SOP adherence.

The role emphasizes leadership, project management, and mentoring of SARA staff, with close collaboration across

Qualifications

• Bachelor's degree in a scientific or healthcare discipline.
• 2-3 years relevant work experience.
• Knowledge of GCP, GVP and ICH guidelines.

Responsibilities

• Lead and finalize safety aggregate reports and literature surveillance.
• Act as global lead for safety aggregate reporting and signal management.
• Ensure compliance with SOPs and GDP.
• Provide training and mentoring to SARA staff.
• Interface with clients and internal stakeholders to deliver deliverables.

Skills

Lifecycle Safety

Project management

Leadership

Regulatory knowledge

Attention to detail

Communication skills

Education

Bachelor's Degree in a Scientific or Healthcare discipline

Job description

Safety Aggreg Report Mgr 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 IC SRs 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 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. Contribute to resource needs and resource allocation based on workload to ensure appropriate compliance with report submissions.

Qualifications Bachelor's Degree in a Scientific or Healthcare discipline Req 2 - 3 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 https://jobs.iqvia.com IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

Experience Level Senior Level