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Icsr Case Processing Jobs (NOW HIRING)

Argenx

Medical Safety Lead

Perform the medical assessment of individual case safety reports (ICSR) when required * Provide ... Provide strategic guidance and have oversight on the case processing activities * Partner with ...

Argenx

OR · On-site

Perform the medical assessment of individual case safety reports (ICSR) when required * Provide ... Provide strategic guidance and have oversight on the case processing activities * Partner with ...

Crispr Therapeutics

Senior Manager, Drug Safety

Boston, MA · On-site

$140K - $155K/yr

The successful candidate will work cross-functionally to support Individual Case Safety Report (ICSR) processing and compliance and vendor management. This role will play part in ensuring continuity ...

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Icsr Case Processing information

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$12

$49

$85

How much do icsr case processing jobs pay per hour?

As of Jun 9, 2026, the average hourly pay for icsr case processing in the United States is $49.14, according to ZipRecruiter salary data. Most workers in this role earn between $38.46 and $55.53 per hour, depending on experience, location, and employer.

What are some common challenges faced in ICSR Case Processing, and how can new team members effectively navigate them?

One of the main challenges in ICSR Case Processing is managing high volumes of cases while ensuring accuracy and compliance with regulatory timelines. New team members may also find it challenging to interpret complex medical information and stay updated with evolving global pharmacovigilance regulations. To succeed, it is important to develop strong attention to detail, make effective use of standard operating procedures, and proactively seek clarification from experienced colleagues. Collaboration with medical reviewers and regulatory affairs teams is also key to resolving ambiguities and ensuring the quality of case submissions.

What is the difference between Icsr Case Processing vs Clinical Data Entry Specialist?

AspectIcsr Case ProcessingClinical Data Entry Specialist
CertificationsOften requires knowledge of ICSR regulations and pharmacovigilanceTypically requires data entry or clinical research certifications
Work EnvironmentPharmaceutical or biotech companies, clinical trial settingsResearch organizations, clinical sites, or CROs
Job FocusProcessing and managing individual case safety reports (ICSRs)Entering and verifying clinical trial data into databases

While both roles involve handling clinical data, Icsr Case Processing focuses on managing safety reports and pharmacovigilance, whereas Clinical Data Entry Specialists primarily input and verify clinical trial data. Understanding these differences helps in choosing the right career path or job search focus within the clinical research industry.

What are the key skills and qualifications needed to thrive as an ICSR Case Processor, and why are they important?

To thrive as an ICSR Case Processor, you need a solid understanding of pharmacovigilance principles, medical terminology, and regulatory requirements, typically supported by a life sciences degree or equivalent experience. Familiarity with safety databases like Argus or ARISg and proficiency in using MedDRA coding and case management systems are essential. Attention to detail, strong organizational skills, and clear written communication help ensure accuracy and efficiency in processing cases. These skills are crucial for maintaining compliance, safeguarding patient safety, and supporting the integrity of drug safety reporting processes.

What is ICSR case processing?

ICSR case processing refers to the handling and evaluation of Individual Case Safety Reports (ICSRs) within the pharmacovigilance process. These reports detail adverse events or side effects experienced by patients after using a pharmaceutical product. The processing involves data entry, assessment, coding, narrative writing, and submission to regulatory authorities. The main goal is to ensure patient safety and regulatory compliance by accurately documenting and reporting any potential risks associated with drugs. Professionals in this role play a crucial part in monitoring and improving drug safety worldwide.
Infographic showing various Icsr Case Processing job openings in the United States as of May 2026, with employment types broken down into 95% Full Time, and 5% Contract. Highlights an 76% In-person, and 24% Remote job distribution, with an average salary of $102,217 per year, or $49.1 per hour.

Drug Safety Operations Associate

The Rockridge Group

Stamford, CT • On-site

Full-time

Posted 12 days ago

Job description

TITLE: Drug Safety Operations Associate
LOCATION: Stamford, CT
DURATION: 12 months
Job Description:
  • Position performs adverse event processing and submission responsibilities supporting the Case Management function within Drug Safety Operations.
Primary Responsibilities
  • Perform case processing activities (triage, data entry, report distribution) as required
    • Assess, process, and data enter all AE case types to meet compliance requirements
    • Perform triage on all case types to determine prioritization (if requested by Purdue)
    • Identify adverse events, seriousness, and listed Ness / labeled Ness for case assessment; review additional incoming information to determine reportability
    • Select the appropriate as reported causality and company causality
    • Perform all appropriate coding using MedDRA, WHO-DRUG, and Company Product dictionaries.
    • Own case narrative - create narrative text as required for medical orientation
    • Determine follow-up requirements and request follow-up as appropriate (e-mail, phone call, letter, etc.) to request additional information
    • Support ICSR submissions and transmissions as needed.
    • Perform CRO case QC activities, reconciliation etc as required.
    • Work on highest priority or assigned cases using Workflow Management System, or as directed
    • Participate in inspections and audits as identified, including interviews and provision of requested data
    • Meet KPIs/KQIs as designated by Purdue and in compliance with company guidelines and policies
    • Assist in writing late ICSR related deviations and CAPAs, upon request
    • Perform additional tasks as assigned. Work independently, assess matters, propose resolutions, and appropriately escalate internally within Purdue organization
Education and Experience Requirements:
  • Bachelor’s degree (advanced degree preferred) in life science or healthcare (e.g. nursing, pharmacy)
  • Five (5+) years of experience in a pharmaceutical/biopharmaceutical company
  • Three (3+) years in Drug Safety Operations role;
  • Experience overseeing CRO teams of case processors preferred
  • US FDA pharmacovigilance inspection experience preferred
Necessary Knowledge, Skills, and Abilities:
  • Resource and workflow management (monitoring and assigning tasks)
  • Up-to-date knowledge of US and international PV regulations and best practices
  • MedDRA coding
  • Considers present and future impacts when making recommendations
  • Strong negotiation and problem-solving skills
  • Analytical skills and attention to detail
  • Accountability – takes ownership of deliverables
Necessary Knowledge, Skills, and Abilities:
  • Resource and workflow management (monitoring and assigning tasks)
  • Up-to-date knowledge of US and international PV regulations and best practices
  • MedDRA coding
  • Considers present and future impacts when making recommendations
  • Strong negotiation and problem-solving skills
  • Analytical skills and attention to detail
  • Accountability – takes ownership of deliverables