Senior Safety Reporting Specialist, U.S. or Mexico, Home-Based - IQVIA Biotech
Company: IQVIA Holdings Inc
Posted on: June 12, 2021
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
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
- Provides input and review of responses to regulatory agency
questions with regard to safety/ pharmacovigilance activities.
- Maintains awareness of reporting timelines for aggregate safety
- Tracks regulatory submissions in the safety database or project
specific tracking tool, as applicable.
- Assists in conducting root cause analysis for any late
- Performs vendor compliance reconciliation as required per
- 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
- 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
- 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
- Good knowledge of Medical Device regulations, both pre-and
- Excellent knowledge of electronic safety databases (preferable
- 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
- 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
- Previous experience in medical device trials preferred.
- Appropriate clinical research experience including electronic
data management systems, EDC, safety database usage (Argus
- Excellent knowledge of issues affecting
Safety/Pharmacovigilance reporting for clinical trials of IMPs and
- Prior experience with Eudravigilance submissions
- 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
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 70,000+
employees around the world who apply their insight, curiosity and
intellectual courage every step of the way. Learn more at
All qualified applicants will receive consideration for
employment without regard to race, color, religion, sex, sexual
orientation, gender identity, national origin, disability, status
as a protected veteran, or any other status protected by applicable
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
Keywords: IQVIA Holdings Inc, Cambridge , Senior Safety Reporting Specialist, U.S. or Mexico, Home-Based - IQVIA Biotech, Other , Cambridge, Massachusetts
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