Medical Review Scientist

Randstad Life Sciences US; Thousand Oaks (CA); Remote; USD 150,000 - 200,000; Full time

Job summary

A leading staffing and recruitment partner is seeking a Drug Safety Associate for a contract role with a global biotechnology leader. The position involves medical review of ICSRs, quality assurance, and ensuring compliance with safety standards. Ideal candidates will have a nursing degree and relevant experience in drug safety, contributing to innovative therapies in oncology, cardiology, and bone health.

Benefits

Comprehensive benefits package

Medical, prescription, and dental coverage

401K plan

Qualifications

• Clinical Nursing qualification + 1 year drug safety experience.
• Nursing Degree + 3 years relevant work experience.
• Medical review of ICSRs (narratives, coding, expectedness, causality, seriousness).
• Quality Assurance of ICSR medical review.
• Clinical knowledge of therapeutic area patient populations and drug class.

Responsibilities

• Execute the medical review of ICSRs to ensure quality reports.
• Maintain a state of inspection readiness.
• Support medical coding conventions and process improvements.

Skills

Quality Assurance

ICSR (Individual Case Study Report)

QC Review

Education

Bachelors

Job description

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Job Summary

As a trusted staffing and recruitment partner, we are committed to connecting you with the perfect opportunity at a global leader in biotechnology. Leveraging our extensive network, we provide access to top-tier roles that allow you to grow and make a meaningful impact in the healthcare and life sciences industries. This company is dedicated to discovering and developing innovative therapies that address serious diseases, with a focus on oncology, cardiology, and bone health. With a strong legacy of scientific excellence and a mission to improve patient outcomes worldwide, they offer a dynamic environment where your contributions will drive real change. If you're seeking a rewarding career that makes a difference, let us help you take the next step!

Job Summary

As a trusted staffing and recruitment partner, we are committed to connecting you with the perfect opportunity at a global leader in biotechnology. Leveraging our extensive network, we provide access to top-tier roles that allow you to grow and make a meaningful impact in the healthcare and life sciences industries. This company is dedicated to discovering and developing innovative therapies that address serious diseases, with a focus on oncology, cardiology, and bone health. With a strong legacy of scientific excellence and a mission to improve patient outcomes worldwide, they offer a dynamic environment where your contributions will drive real change. If you're seeking a rewarding career that makes a difference, let us help you take the next step!

Key Skills

• Nursing degree needed
  
  

Drug Safety

Pharmacovigilance

Medical review/ Safety Review

location: Telecommute

job type: Contract

salary: $60.00 - 69.09 per hour

work hours: 9 to 5

education: Bachelors

Responsibilities

Responsibilities

• Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. Produce medically accurate ICSRs reports
• Act as MSRT product lead as assigned
• Execute ICSR case escalation as appropriate
• Execute appropriate case follow up per SOPs
• Support medical coding conventions, and systematic process improvements for ICSR medical review
• Maintain list of expected terms in the auto label tool
• Support Quality Assurance of ICSR medical review
• Participate in Safety Assessment Team (SAT) (if applicable)
• Conduct reportability assessment for medical device associated events and /or product complaint associated events, and review for potential product problems
• Provide input on teams for interdepartmental and cross-functional initiatives (if applicable)
• Perform other duties related to the position as necessary as defined in SOPs or as requested by his/her supervisor
  
  

Inspection Readiness

• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
• Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
  
  

Qualifications

Required:

• Clinical Nursing qualification + 1 year drug safety experience.
• Nursing Degree + 3 years relevant work experience.
• Medical review of ICSRs (narratives, coding, expectedness, causality, seriousness).
• Quality Assurance of ICSR medical review.
• Clinical knowledge of therapeutic area patient populations and drug class.
  
  

skills: Quality Assurance, ICSR (Individual Case Study Report), QC Review

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.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Contract

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Pharmaceutical Manufacturing

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