Clinical Safety Data Specialist (RN / PharmD / MD)

Randstad USA; North Chicago (IL); À distance; USD 42 000 - 59 000; Temps partiel

Résumé du poste

Randstad USA is seeking a detail-driven Medical Reviewer II to support clinical safety teams on a 2-year remote contract. The role involves reviewing adverse events, data queries, and safety narratives across immunology, oncology, and neurology trials.

Candidates must bring bedside acute care experience and one of the listed credentials. The position is fully remote in the United States with standard hours and a competitive hourly rate.

Qualifications

• 2+ years direct acute care bedside clinical experience.
• One of: BSN with active RN licensure, PharmD with hospital/clinical pharmacist experience, or MD/MBBS.
• Eligible to work in the U.S. without sponsorship.

Responsabilités

• Review adverse events, lab results, vital signs, and concomitant medications within EDC/safety repositories.
• Conduct deep-dive data investigations on clinical safety information to identify potential study-level trends.
• Draft comprehensive safety narratives and evaluate adverse event reporting for regulatory compliance.
• Issue and resolve clinical queries with trial sites to clarify ambiguous or inconsistent patient data.
• Partner cross-functionally with safety teams to ensure strict adherence to FDA, EMA, and ICH surveillance guidelines.

Connaissances

Critical thinking

Microsoft Office

Excel

Word

Formation

BSN with RN

PharmD

MD/MBBS

Outils

Medidata Rave

Veeva

Description du poste

Job Summary

Looking to transition your acute care bedside experience into life sciences? A top-tier global biopharmaceutical leader is seeking a detail-driven clinician for a 100% remote Medical Reviewer/Safety Reviewer II position. Candidates can be based anywhere in the U.S. and will serve as the core clinical support partner to Clinical Safety Associates, investigating patient safety data across high-impact immunology, oncology, and neurology clinical trials.

location: Remote
job type: 2 year contract
pay: $36.65 / hour
work hours: Standard working hours
education: BSN, RN, PharmD, MD/MBBS

Responsibilities

• Review adverse events, lab results, vital signs, and concomitant medications within EDC/safety repositories.
• Conduct deep-dive data investigations on clinical safety information to identify potential study-level trends.
• Draft comprehensive safety narratives and evaluate adverse event reporting for regulatory compliance.
• Issue and resolve clinical queries with trial sites to clarify ambiguous or inconsistent patient data.
• Partner cross-functionally with safety teams to ensure strict adherence to FDA, EMA, and ICH surveillance guidelines.
  

Qualifications

required:

• Minimum 2 years of direct acute care bedside clinical experience (e.g., ICU, ER, Med-Surg).
• One of the following clinical credentials:
• BSN degree with active, unencumbered U.S. Registered Nurse (RN) licensure.
• PharmD with registered hospital/clinical pharmacist experience.
• MD/MBBS (foreign-trained medical degree accepted with bedside experience).
• Permanent U.S. work authorization (sponsorship not available).
• Demonstrated critical thinking skills with proficiency in Microsoft Office (Excel, Word).

Preferred

• Prior pharmaceutical, biotech, or CRO safety surveillance experience.
• Hands-on familiarity with EDC platforms such as Medidata Rave or Veeva.

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 [e-mail].

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.