Job Description
job summary:
Step into a high-impact, fully remote role where your medical expertise directly safeguards patient safety and ensures global regulatory compliance. This year-long contract offers a competitive rate of $51-$70/hr and the flexibility of a standard Monday-through-Friday schedule aligned with either EST or PST time zones. As a Medical Reviewer, you will leverage your MD or MBBS background and specialized oncology experience to perform sophisticated medical reviews of ICSRs from various sources, including clinical trials and post-marketing reports.
You will lead critical causality assessments using the WHO algorithm and perform seriousness and labeling evaluations against standards like the USPI, SmPC, and CCDS. Working within Argus and utilizing MedDRA coding, you will identify potential signals and collaborate with global safety teams to maintain the highest levels of data integrity. This position is an ideal fit for a PV professional with 3-4 years of experience who thrives on critically evaluating complex safety data to influence clinical development and strategic safety practices.
location: Telecommute
job type: Contract
salary: $51 - 70 per hour
work hours: 9 to 5
education: Doctorate
responsibilities:
- Reviews all applicable ICSRs, and communicates with Global Case Management Team, Medical Safety Management team within Medical Safety, and others, such as CROs, or vendors, when necessary
- Perform medical review all types of Individual case safety reports (ICSR) from all sources such as health authority reports, clinical trials, post marketing spontaneous, literature, solicited reports
- Perform causality assessment for all events based on WHO algorithm and ICH guidelines also taking into consideration company conventions and creates company clinical evaluation comment
- Perform seriousness assessment and labeling assessment for adverse events with reference to different types of product safety information such as USPI, Canadian Product Monograph, SmPC, CCDS, IB
- Medical review of MedDRA coding of adverse events, indications, laboratory data, medical history or surgical procedures and narratives
- Raise follow up queries for additional information needed for medical assessment
- Review, identify potential signals from ICSRs and escalates issues / concerns to team lead in a timely and appropriate manner
qualifications:
Required:
- A Medical degree (MD or MBBS), or internationally recognized equivalent, from an accredited medical school
- At least 3-4 years of experience in PV, as ICSR Medical Reviewer, primary clinical cases, oncology experience
- Knowledge of medical aspects of drug safety in pre- and post-marketing safety practice
- PV regulations knowledge including but not limited to ICSRs processing, aggregate safety reports, risk management plans, and signal management in different jurisdictions.
- In-depth knowledge of medical and drug terminology, as well as the clinical development process.
- Knowledge with MedDRA coding and Argus safety databases.
- Proficiency with Windows applications, and ability to learn new programs / databases.
- Ability to critically evaluate safety data from multiple sources (clinical trials, literature, etc.), assesses clinical importance and potential strategic impact of the data and present the findings clearly in both written and oral communication.
#LI-KH1
skills: Oncology, Drug Safety, Individual Case Safety Report (ICSR), International Council for Harmonization (ICH)
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.
Any consideration of a background check would be an individualized assessment based on the applicant or employee's specific record and the duties and requirements of the specific job.
Job Tags
Hourly pay, Contract work, Temporary work, Work experience placement, Remote work, Monday to Friday