Apply for Manager, Safety Aggregate Reporting at IQVIA
Manager, Safety Aggregate Reporting
Job Type: Full-Time
Job Responsibilities:
Job Overview
Line Manager Responsibilities
Essential Functions
• Line manager of staff, based at one or more sites.
• Responsible for performance of direct reports (quality, compliance, productivity, profitability, utilizsation). Responsibilities include planning, assigning, resourcing and directing work and deliverables
• nboarding, coaching, mentoring, appraising performance against business goals, core compentencies, and policies
• guiding professional development
• rewarding and constructively and professionally disciplining employees, addressing employee relations issues and resolving problems. Approve or reject actions as applicable on human resources matters.
• Works with senior management to understand and interpret system business unit (SBU) strategy and effectively communicate and implement across direct line reports
• Serve as a stand-alone global lead for aggregate reporting, signal management, or literature survellance projects
• and may need to jump into the workflow as required to maintain compliance.
• 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.
• Attend and participate in Bid Defenses, Kick off Meetings (KOM), as applicable.
• Support Request for Information (RFI), Request for Pricing (RFP), and budgets, as requested.
• Support employee engagement initiatives
• Act as the first line point of contact (POC) for escalations.
• Participate / Support internal and external audits and inspections, as required.
• Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics.
• Support, contribution, &/or resource technology / innovation activities.
• 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 to maintain compliance and documented.
• 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).
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
• People & Project Management Experience or Proven People Management Skills. Advanced
• Good understanding of Standard Operating Procedures (SOPs) and work instructions applicable to the role. Advanced
• Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint). Advanced
• Good knowledge of medical terminology. Advanced
• Strong organizational skills, metrics calculations, and time management skills. Advanced
• Strong verbal/written communication skills. Advanced
• Self-motivated and flexible. Advanced
• Excellent attention to detail and accuracy. Advanced
• Ability to follow instructions/guidelines, utilize initiative and work independently. Advanced
• Proven ability to multi-task, manage competing priorities and deadlines. Advanced
• Willingness and aptitude to learn new skills across all Lifecycle Safety service lines. Advanced
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