We're looking for an experienced Medical Reviewer to join our team on a remote basis. In this role, you'll be responsible for the medical review of Individual Case Safety Reports (ICSRs) from a variety of sources. You'll need to have a strong background in pharmacovigilance (PV), with a focus on safety data evaluation, MedDRA coding, and working within the Argus safety database. A valid MD degree and medical license are required for this position.
Must work EST.
location: Philadelphia, Pennsylvania
job type: Contract
salary: $125.00 - 133.20 per hour
work hours: 9 to 5
education: Doctorate
responsibilities:
- Case Review & Communication: You'll review and medically assess all applicable ICSRs and communicate with various internal and external teams, including Global Case Management, Medical Safety Management, CROs, and vendors.
- Medical Assessment: Perform medical reviews of all ICSR types from sources like clinical trials, post-marketing reports, literature, and health authority reports.
- Causality & Seriousness: Conduct causality assessments for all events based on WHO algorithms and ICH guidelines. You'll also perform seriousness and labeling assessments using product safety information such as USPI, SmPC, CCDS, and IB.
- Data Review: Medically review MedDRA coding for adverse events, indications, medical history, and narratives. You'll also raise follow-up queries to gather additional information for a complete medical assessment.
- Signal Detection: Proactively identify potential signals from ICSRs and escalate any issues or concerns to the team lead in a timely manner.
qualifications:
Requirements:
- MD degree and an active medical license in at least one country.
- 3+ years of recent experience as an ICSR Medical Reviewer in pharmacovigilance, with a strong understanding of both pre- and post-marketing drug safety.
- 3+ years of hands-on experience with the Argus safety database and demonstrated proficiency in MedDRA coding.
- In-depth knowledge of PV regulations, including the processing of Individual Case Safety Reports (ICSRs), aggregate safety reports, and signal management.
skills: MS-WORD, MS-EXCEL, ICH Regulations, MedDRA, Individual Case Safety Report (ICSR), Safety Data Analysis
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.
