Manager, Regulatory Reporting Team

3-7 years

Not Disclosed

Dublin

10 Oct. 3, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Role Overview

This position is responsible for managing Safety staff engaged in Regulatory Reporting Operations, ensuring alignment with departmental and corporate standards. The role involves contributing to global initiatives and collaborating closely with relevant stakeholders to meet both local and global deliverables and metrics.

Main Responsibilities

Collaborate effectively with Safety Management in a matrix framework to achieve project and customer deliverables.
Develop and implement strategies to measure and enhance employee engagement, ensuring global consistency.
Work alongside project leads to assess scheduling for current and upcoming projects, staffing requirements, technological needs, and projected peak workloads, aiming for global consistency where feasible. Create and manage action plans to ensure accountability among team members.
Communicate messages from leadership to direct reports and teams, while effectively relaying issues and opportunities back to leadership.
Conduct meetings with direct reports to discuss project status, including timelines, delivery updates, financial aspects, potential risks, mitigation strategies, team utilization rates, training obligations, and personnel matters.
Participate in Bid Defenses and Kick-off Meetings (KOM) as needed. Assist with Requests for Information (RFI), Requests for Pricing (RFP), and budgeting as required.
Serve as a designated substitute or ensure coverage for direct reports during their absence or in the event of turnover.
Support internal and external audits and inspections as required, ensuring that the necessary staff are assigned, trained, and prepared.

Minimum Required Education and Experience

Bachelor's Degree in a scientific or healthcare discipline or a related life sciences field.
Up to 7 years of relevant experience, including a maximum of 4 years in Pharmacovigilance and up to 3 years in line management.
Comprehensive knowledge of Safety service lines.
Proven staff management capabilities, along with strong leadership, motivational, and influencing skills.
Excellent organizational, metric calculation, and time management skills.
Strong verbal and written communication skills.
Ability to handle multiple projects and manage competing priorities effectively.
Effective mentoring and coaching abilities.
Capability to achieve results through proactive communication and facilitation in a matrix service delivery environment with shared accountabilities.
Sound judgment, decision-making, and problem-solving skills.
Ability to drive short- and long-term business and financial results.
Proactive evaluation of risks and potential issues, seeking solutions and discussing them appropriately with direct reports, colleagues, and customers.

About IQVIA

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments, improving patient outcomes and population health worldwide.

Learn more about opportunities at IQVIA by visiting our careers page.

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Manager, Regulatory Reporting Team

Job Description

Role Overview

Main Responsibilities

Minimum Required Education and Experience

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