Safety Aggreg Report Spec

Safety Aggreg Report Spec 1

Job Overview
Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements.

Essential Functions

• Act as primary author & or reviewer/QCer of SARA deliverables involving aggregate reports, signal management or literature review projects.

• Lead, author and finalize small to medium aggregate reports, including but not limited to PBRERs/PSURs, DSURs, PADERs, ACOs, device reports, and line listings

• author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required.

• Act as literature lead, back-up lead, reviewer/QCers to contribute in the conduct of ongoing literature safety surveillance for marketed and investigational products with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. Author and/or contribute to literature deliverables for aggregate reports &/or signal management activities meeting strict regulatory timelines.

• Act as Signal Management Specialist on post-marketing and clinical trial projects. Author all types of signal management deliverables. 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 characterization of risks. Participate as core member and present in safety management teams. Responsible for full documentation and tracking of signals.

• In a PV support role, author 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 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 to maintain compliance 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, 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.

• Support and/or contribute to technology / innovation activities.
Generates, analyzes, and summarizes aggregate safety data to discern new signals and, as required, commences benefit-risk evaluation and determines risk-mitigating activity.
Collaborates with client and regulatory stakeholders and internal project teams to determine the safety analysis required; performs the search for applicable safety data; aggregates, analyzes, and archives the safety data; completes templates for reporting and evaluating signals or benefit-risk analysis; and publishes and submits aggregate safety reports to regulatory bodies on behalf of contracted clients and corresponds with regulatory bodies as required.

Qualifications

• Bachelor's Degree Bachelor's Degree Req

• 1 - 3 years of prior relevant experience in areas of drug safety, aggregate reporting, signal management, or literature surveillance. Pref

• Equivalent combination of education, training and experience. Req

• Good understanding of Standard Operating Procedures (SOPs) and work instructions applicable to the role. Intermediate

• Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint). Intermediate

• Good knowledge of medical terminology. Intermediate

• Strong organizational skills and time management skills. Intermediate

• Strong verbal/written communication skills. Intermediate

• Self-motivated and flexible. Intermediate

• Excellent attention to detail and accuracy. Intermediate

• Ability to follow instructions/guidelines, utilize initiative and work independently. Intermediate

• Proven ability to multi-task, manage competing priorities and deadlines. Intermediate

• Willingness and aptitude to learn new skills across all Lifecycle Safety service lines. Intermediate

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