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Verastem

Senior PV Operations Specialist

Boston, MA · On-site

$116K - $143K/yr

Oversee day-to-day ICSR operational activities, processes, training and compliance of PV case processing vendor. * Ensure timely submission compliance of ICSRs to global regulatory authorities ...

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$12

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How much do icsr jobs pay per hour?

As of Jun 18, 2026, the average hourly pay for icsr 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 the typical daily responsibilities for an ICSR professional in pharmacovigilance?

ICSR professionals are responsible for collecting, evaluating, and processing adverse event reports from various sources such as healthcare professionals, patients, and clinical trials. Their daily tasks often include data entry into specialized safety databases, coding of medical terms (using MedDRA), preparing case narratives, and ensuring timely submission of safety reports to regulatory authorities. Collaboration with safety physicians, regulatory teams, and quality assurance colleagues is common, as accuracy and compliance are essential. This role requires managing multiple cases simultaneously while maintaining high standards for data integrity and regulatory timelines.

What are the key skills and qualifications needed to thrive in the Icsr position, and why are they important?

To thrive as an ICSR (Individual Case Safety Report) professional, you need strong attention to detail, a background in life sciences or pharmacy, and familiarity with pharmacovigilance practices. Proficiency in safety databases (such as ArisG or Oracle Argus), MedDRA coding, and regulatory reporting requirements is highly valuable, and some roles may prefer certification in pharmacovigilance. Excellent organizational skills, critical thinking, and clear written communication help ensure thorough and accurate case processing. These abilities are crucial to maintaining regulatory compliance, ensuring patient safety, and supporting effective drug safety monitoring.

What is an ICSR job?

An ICSR (Individual Case Safety Report) job involves the processing and reviewing of adverse event reports related to pharmaceutical products or medical devices. Professionals in this role ensure that safety data is accurately documented and reported to regulatory authorities in compliance with guidelines such as those from the FDA, EMA, or ICH. They analyze case information, categorize adverse events, and contribute to pharmacovigilance efforts to enhance patient safety.

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Icsr jobs near you

Drug Safety Operations Associate

The Rockridge Group

Stamford, CT

Full-time

Posted 21 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