Safety Aggregate Reporting Specialist 2

Safety Aggregate Reporting Specialist 2 will be based in Dublin and the role will be homebased

during COVID-19 with flexibility to hot desk thereafter.

Summary:

Apply knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents. Ideal candidate will have some Aggregate reporting experience.

Key responsibilities:

• Prior Aggregate reporting experience highly desirable
• Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings
• Interact with the client on regular basis- attend internal and external team meetings
• 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), and Information Technology (IT), as needed.
• Participate in internal and external audits and inspections, as required.
• Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA).
• author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required.
• In a PV support role, lead/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents.
• Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics.
• 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 and documented.
• Serve as the interface between the global project lead and the working team
• Conduct regular lessons learned 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, 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. Ensure Good Documentation Practices (GDP).
• Support and/or contribute to technology / innovation activities.

Minimum Required Education and Experience:

• Bachelor's Degree Bachelor's Degree ( or Masters or PharmD.  Science / health care such as pharmacy, pharmacology, nursing)
• A few years relevant work experience.  If you have Prior Aggregate reporting experience this is a bonus

Skills & Abilities:

• Excellent written and spoken English
• Equivalent combination of education, training and experience.
• Excellent knowledge of Lifecycle Safety services and processes.
• Willingness and aptitude to learn new skills across Lifecycle Safety service lines.
• In depth knowledge and understanding of applicable global, regional, local regulatory requirements.
• Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and International Conference of Harmonization (ICH) guidelines, SOPs.
• Proven ability to meet strict deadlines.
• Manage competing priorities and ability to be flexible and receptive to changing demands.
• Excellent organizational skills and time management skills.
• Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, PowerPoint).
• Good knowledge of medical terminology.
• Proven ability to follow instructions/guidelines, work independently and on own initiative.
• Excellent attention to detail and accuracy maintaining consistently high-quality standards.
• Excellent written/verbal communication and report writing skills.
• Sound judgment.
• Independent thinking and decision-making skills.
• Self-motivated and flexible.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Effective mentoring and coaching skills.
• Good understanding of operational metrics, productivity and initiatives.
• Demonstrate effective project management and leadership skills.

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients. Forge a career with greater purpose, make an impact, and never stop learning.

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At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.