Job Title - Safety Aggregate Reporting Manager.

Skills Needed - Aggregate Reports Authoring.

Years of exp required - 7+ years in AR authoring.

Work Location - Anywhere in India.

Work Mode - Hybrid/Home Based.

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.

• 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.