Job Description
job summary:
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.
location: Telecommute
job type: Contract
salary: $35.00 - 42.87 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Oversee ICSR case processing compliance and monitor the dedicated team mailbox.
- Perform rigorous quality checks, grading, and reviews on adverse event cases processed by the vendor.
- Utilize quality assessment feedback to develop and deliver targeted micro-trainings to vendor teams.
- Collaborate closely with the internal Quality and Standards department to maintain compliance.
- Provide essential support and documentation during regulatory audits and inspections.
qualifications:
Required: - Active Registered Nurse (RN) license or BSN degree.
- Proven clinical nursing experience within a hospital setting (e.g., ICU, ER, Critical Care, or Cardiac).
- Demonstrated experience in Pharmacovigilance (PV) and ICSR case processing.
- Strong knowledge of global safety regulations and guidelines (FDA, ICH, EMEA, MHRA).
- Exceptional attention to detail and strong collaborative communication skills.
Preferred: - Prior experience providing quality oversight or performance monitoring for third-party vendors.
- Hands-on experience utilizing the Veeva Safety global database.
#LI-AO1 skills: Drug Safety, Adverse Event (AE) Reporting, Case Processing, Serious Adverse Event (SAE) Reporting
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.
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.
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).
This posting is open for thirty (30) days.
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.
Job Tags
Hourly pay, Contract work, Temporary work, Work experience placement