IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
IQVIA Biotech is seeking a Safety Coordinator (Office based preferred in our Morrisville, NC location). Argus experience a plus.
Assists with delivery of Safety Management Department services according to ICH-GCP guidelines, regulatory requirements and IQVIA Biotech SOPs and/or project specific procedures.
Primary responsibilities include intake and triage of incoming safety events and related data.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
- Performs intake and triage of incoming safety events and related data including, but not limited to:
- Monitoring and review of safety email box, safety fax and SAE hotline.
- Printing of incoming documents.
- Identifying and blinding all patient identifiers.
- Identifying relevant study and event being reported, including determining if information is new information or follow-up to a previously reported event.
- Creating new or locating existing case file.
- Completing tracking of incoming documents.
- May perform additional case processing tasks such as initial data entry into safety database, assembly of case documentation and submission to sponsor for pass-through studies.
- Responsible for the initial set-up and ongoing maintenance of safety case files.
- Assists with developing and maintaining tracking reports related to progress of studies, communicating regularly with Safety Management Lead and team on status of activities.
- Receives and documents incoming SAE hotline calls.
- Assists with preparing safety reports for submission to Sponsors, Regulatory Authorities or Investigators.
- Assists with performing project related study close-out and archival tasks.
- May assist management and/or Safety Management Lead in writing processes and developing documents related to intake/triage functions, including study-specific processes.
- Provides general administrative support to projects as requested (e.g., taking minutes, copying, filing, faxing, scheduling).
- May mentor and/or train new Safety Management staff.
- Performs other duties as assigned.
KNOWLEDGE, SKILLS AND ABILITIES:
- Good written and verbal communication skills.
- Positive attitude and ability to interact with all levels of staff to successfully coordinate and execute Safety Management department activities.
- Excellent organization skills and ability to handle multiple priorities while adhering to applicable timelines.
- Ability to work independently, follow instructions/guidelines and demonstrate initiative with oversight.
- Basic knowledge of medical terminology.
- Good knowledge of the clinical research process and current GCP/ICH guidelines applicable to conduct of clinical research.
- Strong time management skills.
- Demonstrates professionalism and presents a positive image of the company.
- Prioritizes time effectively based on project needs. Consistently meets deadlines. Seeks management input with any difficulties in establishing priorities.
- Identifies personal career development goals and opportunities related to current job. Solicits and applies performance feedback.
- Demonstrates commitment, dedication, cooperation, positive behavior, adaptability and flexibility with changes in responsibilities and duties.
- Demonstrates honesty and integrity in dealing with others. Works effectively with different types of people. Accepts constructive feedback without becoming defensive.
- Seeks input from others when faced with a difficult situation. Makes sound decisions within the scope of responsibility. Focuses on resolving problems rather than placing blame.
- Establishes and maintains effective relationships with customers (internal and external) and gains their trust and respect. Provides customers with complete and accurate information. Maintains a high energy level when interacting with customers. Acts with the customer in mind.
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
- Very limited physical effort required to perform normal job duties
MINIMUM RECRUITMENT STANDARDS:
- Bachelor's Degree in one of the life sciences or clinical research and a minimum of 1 year of related clinical research experience.
- Equivalent combination of relevant education and experience.
- Prior experience in clinical trial safety preferred.
- Computer literacy and experience working with Microsoft Office (Word, Excel) required.
- Good written and verbal communication skills required.
- Good interpersonal and organization skills required.
- Ability to work independently, prioritize effectively and work within a matrix team environment required.
This position is classified as non-exempt; employees are eligible for overtime compensation subject to prior approval.
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.
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.
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