IQVIA Safety Reporting Specialist, IQVIA Biotech in Cambridge, Massachusetts
IQVIA Biotech is seeking a Safety Reporting Specialist (Home-Based):
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.
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.
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 under the direction of management.
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.
Participates in developing processes and writing documents related to safety reporting, including study-specific processes.
Participates in 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.
Prioritizes time effectively based on project needs. Consistently meets deadlines. Seeks management input with any difficulties in establishing priorities.
Ability to understand and follow regulatory legislation and guidelines.
Good 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.
Good knowledge of electronic safety databases (preferable including Argus).
Good knowledge of electronic safety reporting systems (e.g. EudraVigilance, safety database gateway).
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 3 years of related pharmacovigilance experience or relevant combination of education and experience.
Appropriate clinical research experience including electronic data management systems, EDC, safety database usage (Argus experience preferred).
Knowledge of issues affecting Safety/Pharmacovigilance reporting for clinical trials of IMPs and medical devices.
Prior experience with Eudravigilance submissions preferred.
Previous experience in medical device trials preferred.
Computer literacy and experience working with Microsoft Office (Word, Excel) required.
Good interpersonal and organization skills required.
Ability to 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 email@example.com to arrange for such an accommodation.
At IQVIA, we have a vision. Where every healthcare decision is based on evidence. Where data science and human science come together to improve global health. Where new and creative solutions aren’t just possible – they are expected.
Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare. The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease. We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you’re supported to succeed.
- IQVIA Jobs