Remote Drug Safety Nurse - Vendor Oversight
<strong>Job Summary<br><br></strong>Are you a Registered Nurse with pharmacovigilance expertise looking to impact global patient safety? A Top-Tier Global Pharma Leader is seeking a Clinical Medical Services Specialist III for a 1-year, 100% Remote contract. This position requires core working hours aligned with Central Standard Time (CST), specifically 7:00 AM to 4:00 PM. In this role, you will act as a critical quality gatekeeper, ensuring global regulatory compliance by overseeing Individual Case Safety Report (ICSR) processing conducted by an offshore vendor.<br><br>location: Telecommute<br><br>job type: Contract<br><br>salary: $35.00 - 42.87 per hour<br><br>work hours: 9 to 5<br><br>education: Bachelors<br><br><strong>Responsibilities<br><br></strong><ul><li>Oversee ICSR case processing compliance and monitor the dedicated team mailbox.</li><li>Perform rigorous quality checks, grading, and reviews on adverse event cases processed by the vendor.</li><li>Utilize quality assessment feedback to develop and deliver targeted micro-trainings to vendor teams.</li><li>Collaborate closely with the internal Quality and Standards department to maintain compliance.</li><li>Provide essential support and documentation during regulatory audits and inspections.<br><br></li></ul><strong>Qualifications<br><br></strong><strong>Required:<br><br></strong><ul><li>Active Registered Nurse (RN) license or BSN degree.</li><li>Proven clinical nursing experience within a hospital setting (e.g., ICU, ER, Critical Care, or Cardiac).</li><li>Demonstrated experience in Pharmacovigilance (PV) and ICSR case processing.</li><li>Strong knowledge of global safety regulations and guidelines (FDA, ICH, EMEA, MHRA).</li><li>Exceptional attention to detail and strong collaborative communication skills.<br><br></li></ul><strong>Preferred<br><br></strong><ul><li>Prior experience providing quality oversight or performance monitoring for third-party vendors.</li><li>Hands-on experience utilizing the Veeva Safety global database.<br><br></li></ul>skills: Drug Safety, Adverse Event (AE) Reporting, Case Processing, Serious Adverse Event (SAE) Reporting<br><br>Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.<br><br>At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.<br><br>Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).<br><br>This posting is open for thirty (30) days.<br><br>It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.<br><br>u00006475229<br><br>