Safety Aggregate Report Spec 2

Job Overview
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.

Essential Functions
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).
Lead author and finalize aggregate reports including but not limited to PBRERs/PSUR DSURs PADERs RMPs ACOs and line listings
author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries as required.
Conduct/Lead 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 review.
Act as Signal Management Lead on postmarketing and clinical trial projects. Setup implement organize (including documentation) and lead safety management teams. Setup and update products signaling strategies. Author and/or QC review all types of signal management deliverables. Lead/ 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 . Responsible for full documentation and tracking of signals.
In a PV support role lead/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents.
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.
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.

Qualifications
Bachelors Degree In a Scientific or Healthcare discipline Req
2 3 years relevant work experience. Pref
Equivalent combination of education training and experience. Req
Excellent knowledge of Lifecycle Safety services and processes. Intermediate
willingness and aptitude to learn new skills across Lifecycle Safety service lines. Advanced
In depth knowledge and understanding of applicable global regional local regulatory requirements. Intermediate
i.e. Good Clinical Practice (GCP) Good Pharmacovigilance Practice (GVP) and International Conference of Harmonization (ICH) guidelines SOPs. Intermediate
Proven ability to meet strict deadlines. Advanced
manage competing priorities and ability to be flexible and receptive to changing demands. Intermediate
Excellent organizational skills and time management skills. Intermediate
Good working knowledge of Microsoft Office and webbased applications (e.g. Word Excel Powerpoint). Intermediate
Good knowledge of medical terminology. Intermediate
Proven ability to follow instructions/guidelines work independently and on own initiative. Intermediate
Excellent attention to detail and accuracy maintaining consistently high quality standards. Advanced
Excellent written/verbal communication and report writing skills. Intermediate
Sound judgment. Intermediate
independent thinking and decision making skills. Intermediate
Selfmotivated and flexible. Advanced
Ability to establish and maintain effective working relationships with coworkers managers and clients. Intermediate
Effective mentoring and coaching skills. Intermediate
Good understanding of operational metrics productivity and initiatives. Intermediate
Demonstrate effective project management and leadership skills. Intermediate

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