Medical Safety Monitor (Clinical Trials) (R1109011) in Bratislava, Slovakia at IQVIA™

Date Posted: 1/12/2020

Job Snapshot

  • Employee Type:
    Full-Time
  • Experience:
    Not Specified
  • Date Posted:
    1/12/2020
  • Job ID:
    R1109011

Job Description

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.

PURPOSE

The Medical Safety Monitor is responsible for the oversight of the adverse events and product experiences reported within a clinical trial.

RESPONSIBILITIES

  • Assists with all activities related to establishing and managing all safety-related processes.
  • Reviews all safety related data for various clinical trials.
  • Reviews clinical safety databases.
  • Write Safety narrative reports for all notable clinical events.
  • Support/Author regulatory notifications and filings.
  • Support/Author periodic safety reports to the FDA and IRB/IECs.
  • Support preparation of safety section of clinical study reports, Clinical Expert reviews, clinical section of device reports, and other ad hoc reports documents as needed to support formal (PMA) regulatory filings.
  • Assist in formulating and implementing guidelines and processes in establishing independent safety monitoring boards and committees for clinical trials.
  • Perform MedDRA coding or SOC coding.
  • Work with applicable departments in regard to the activities of the clinical trial(s).

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Assists with all activities related to establishing and managing all safety-related processes.
  • Reviews all safety related data for various clinical trials.
  • Reviews clinical safety databases.
  • Write Safety narrative reports for all notable clinical events.
  • Support/Author regulatory notifications and filings.
  • Support/Author periodic safety reports to the FDA and IRB/IECs.
  • Support preparation of safety section of clinical study reports, Clinical Expert reviews, clinical section of device reports, and other ad hoc reports documents as needed to support formal (PMA) regulatory filings.
  • Assist in formulating and implementing guidelines and processes in establishing independent safety monitoring boards and committees for clinical trials.
  • Perform MedDRA coding or SOC coding.
  • Work with applicable departments in regard to the activities of the clinical trial(s).

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor’s degree or equivalent combination of education and experience. Masters, M.D., PH.D., RN, BSN, Nurse Practitioner or Physician Assistant degree (or the equivalent work experience) strongly preferred. Employee must have a strong clinical orientation and knowledge of diverse therapeutic categories. Minimum of 5-7 years of clinical research experience, preferably at least three years in medical safety and one year in medical devices. Direct patient care is strongly preferred. Adequate knowledge in reviewing, interpreting and reporting medical records.

Join Us

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.



Job ID: R1109011