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Winaxis

ICSR Lead Engineer

Houston, TX · On-site

$97K - $128K/yr

ICSR Lead Engineer - Location: Houston, TX, US (Onsite) - Type: Contract or Full-Time (FTE) - Experience: Up to 20 years - Industry: Oil & Gas, Refinery, Petrochemical Key Responsibilities: - Support ...

Vrtx

Patient Safety ICSR Manager

Boston, MA · Remote

$121K - $182K/yr

The Global Patient Safety ICSR Manager works with a high degree of independence and is proficient at troubleshooting problems to create and execute improved internal procedures, and to ensure ...

Ascendis Pharma A/S

$150 - $160/hr

The Manager, ICSR Management Team reports to the Director, Head, ICSR Management within the Global Patient Safety (GPS) organization. Under the direction of the Director, Head, ICSR Management, is ...

New

NAMSA

Safety Associate

$75K/yr

Writes ICSR narratives. Interprets reported event information, including medical conditions, laboratory results, and medical procedures. Correctly determines relevant follow-up data required for ICSR ...

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$12

$49

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How much do icsr jobs pay per hour?

As of Sep 3, 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 is an ICSR?

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.

What does an ICSR do?

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 as an ICSR?

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.

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Icsr jobs near you
Infographic showing various Icsr job openings in the United States as of August 2026, with employment types broken down into 95% Full Time, and 5% Contract. Highlights an 77% Physical, 6% Hybrid, and 17% Remote job distribution, with an average salary of $102,217 per year, or $49.1 per hour.

Scientist, ICSR Management

Daiichi Sankyo, Inc.

Basking Ridge, NJ • On-site

$100K - $151K/yr

Full-time

Posted 13 days ago

Job description

Scientist, ICSR Management
Job Requisition ID: 2094
Posting Start Date: 8/21/26
At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
Job Summary
This position is responsible for evaluating, and submitting adverse event reports in accordance to DS policy and regulatory authority requirements. This position supports configuration requests and User Acceptance Testing (UAT) . This level interacts within CSPV for the majority of the time, which includes interactions with other DSPD sites and giving ICSR notifications to partners. This position is expected to handle ICSR issues in accordance with SOPs, SOIs, and experience and escalate more complex problems to Level III.
Responsibilities
ICSR Processing: Support intake and adverse event processing activities including data entry (i.e. PQC results). Support follow-up phone calls to reporters. Initiate SAE recon activities in collaboration with CRO management and cross functional groups (i.e data management). Support CAPA investigations related to ICSR adverse event (AE) intake and regulatory submissions activities. ICSR Submission: Includes the daily review and evaluation of DSI bulk reporting.. Monitors daily ICSR pending and negative acknowledgements. Reviews queries and addresses through to resolution. Initiates global system configuration requests, product approvals, and PVAs. Conducts User Acceptance Testing (UAT) for change requests (CRs) to validate CRs and ensure compliance. Case Processing Policies and Procedures: Participates in development of process guides which are used to ensure consistency and compliance in case processing and adherence to regulatory guidelines. Support review for updates of global standard operating procedures (SOPs), training materials, and processes related to adverse event (AE) intake and submission activities. Supports the review of Pharmacovigilance Regulatory Intelligence (PVRI) to assess potential process and compliance impacts.
Qualifications
Education Qualifications
Bachelor's Degree in nursing, pharmacy, or healthcare related field preferred or In lieu of education 4+ years of PV experience is required.
Experience Qualifications
1 or more years of PV experience and knowledge of FDA regulations required
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Salary Range:
USD$100,960.00 - USD$151,440.00
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