IQVIA (Sr.) Safety Reporting Specialist in Dallas, Texas
IQVIA Biotech is seeking a (Sr.) Safety Reporting Specialist with experience in clinical research and prior experience with Eudravigilance submissions preferred:
Delivers global safety reporting services including expedited and periodic safety reporting to Competent Authorities (CA) and Central Ethics Committees (CEC), for investigational medicinal products (IMPs) and Medical Devices (MD) according to ICH-GCP guidelines, regulatory requirements and IQVIA Biotech Standard Operating Procedures (SOPs) and/or project specific procedures.
Primary responsibilities include:
Review, preparation and submission of safety reports (Expedited and Periodic) to all applicable Competent Authorities and Central Ethics Committees within defined timelines for drug clinical trials and medical device clinical investigations.
Generation and maintenance of the global safety reporting plan for individual studies.
Oversight of third party vendors and timely compliance reconciliation of vendor submissions.
Handle EudraVigilance user registration and maintenance
Serve as Responsible Person for Eudravigilance, if assigned
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
Maintains a high level of understanding of applicable safety reporting regulations (FDA and ICH guidance, GCP regulations, EU Directives, country specific requirements etc.).
Assists in the maintenance of the safety reporting regulatory intelligence repository and informing the Safety Management team and project teams of any pertinent updates.
Submits expedited and periodic safety reports to Sponsors, Competent Authorities and Ethics Committees as applicable according to IQVIA Biotech SOPs and the project specific safety reporting plan including any country specific reporting requirements.
Distributes final regulatory reports to Clinical Operations or designee for reporting to Investigators or local IRBs/ECs.
Submits ICSRs electronically through EVWeb or gateway.
Prepares and submits EudraVigilance documents related to user registration and maintenance
Assumes all applicable responsibilities as required for the role of “Responsible Person for EudraVigilance”
Liaises with applicable departments at IQVIA Biotech and/ or the client to ensure timely submission of Expedited and Periodic reports to applicable Regulatory Authorities and Ethics Committees and ensure all submissions are tracking appropriately and maintained in the project folders.
Communicates with Competent Authorities and EMA/Eudravigilance on administrative and routine matters related to electronic safety reporting.
Provides input and review of responses to regulatory agency questions with regard to safety/ pharmacovigilance activities.
Maintains awareness of reporting timelines for aggregate safety reports.
Tracks regulatory submissions in the safety database or project specific tracking tool, as applicable.
Assists in conducting root cause analysis for any late regulatory reports.
Performs vendor compliance reconciliation as required per project
Attends internal and client project team meetings and provides relevant team updates as required.
Assists management with, or takes ownership of, writing processes and developing documents related to safety reporting, including study-specific processes.
Develops processes and writes documents related to safety reporting, including study-specific processes.
Supports departmental process improvement initiatives and collaborates with relevant departments to ensure execution.
Supports business development activities, budget, and proposal input, etc., as required.
Mentors and/or trains other safety reporting staff, as applicable.
Performs other duties as assigned by the Manager, Safety Reporting or above.
KNOWLEDGE, SKILLS AND ABILITIES:
Positive attitude and ability to interact with all levels of staff to successfully coordinate and execute safety reporting activities.
Excellent written and verbal communication skills.
Excellent organization skills and ability to handle multiple priorities while adhering to applicable timelines.
Prioritizes time effectively based on project needs. Consistently meets deadlines. Seeks management input with any difficulties in establishing priorities.
Advanced ability to understand, evaluate and follow regulatory legislation and guidelines.
Ability to work independently, follow instructions/guidelines and demonstrate initiative.
Excellent knowledge of the clinical research process and current GCP/ICH guidelines applicable to conduct of clinical research.
Good knowledge of Medical Device regulations, both pre-and post-marketing.
Excellent knowledge of electronic safety databases (preferable including Argus).
Excellent knowledge of electronic safety reporting systems (e.g. EudraVigilance, safety database gateway).
EudraVigilance certification preferred.
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
Very limited physical effort required to perform normal job duties.
Ability and willingness to travel domestically and internationally, if required (travel requirement <5%).
MINIMUM RECRUITMENT STANDARDS:
Bachelor’s Degree in one of the life sciences or clinical research and a minimum of 5 years of related pharmacovigilance experience and at least 2 years of relevant safety submission experience.
Previous experience in medical device trials preferred.
Appropriate clinical research experience including electronic data management systems, EDC, safety database usage (Argus experience preferred).
Excellent knowledge of issues affecting Safety/Pharmacovigilance reporting for clinical trials of IMPs and medical devices.
Prior experience with Eudravigilance submissions preferred.
Computer literacy and experience working with Microsoft Office (Word, Excel, and PowerPoint) required.
Good interpersonal and organization skills required.
Ability to work independently, prioritize effectively and work within a matrix team environment.
This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.
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 .
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled
IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at firstname.lastname@example.org to arrange for such an accommodation.
IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.
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