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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 ...

TechData Service Company LLC

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Director, Medical Reviewer (Contractor)(Remote) LPTK10113

OR · Remote

$125 - $150/hr

Strong knowledge of general medicine, safety databases, global regulatory expectations, and ICSR assessment. * Ability to work independently in a remote environment while collaborating with global ...

Verastem

Senior PV Operations Specialist

Boston, MA · On-site

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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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

ICSR Lead Engineer

Winaxis

Houston, TX • On-site

$97K - $128K/yr

Contractor

Posted 23 days ago

Be an early applicant

Job description

Job Summary for ICSR Lead Engineer (Houston, TX - Onsite)
- Role: 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 operations and maintenance activities for ICSR (Industrial Control System Risk) systems, including reviewing procedures, access reviews, and cyber KPI reporting.
- Apply and support discipline design standards, specifications, and safety/security criteria.
- Ensure compliance with industry standards (e.g., IEC 62443, NIST Cybersecurity Framework) and regulatory requirements for ICS cybersecurity.
- Support and implement cyber-secure architecture for controls and safety systems.
- Assess and manage cybersecurity controls, providing improvement recommendations.
- Perform and steward risk assessments for control systems, including inventory, risk ratings, identification of controls, and verification of risk-reduction measures.
- Manage and verify security controls for third-party services, including documentation, risk assessments, and certification of external connections.
- Support continuous improvement activities, including audit support, closing audit gaps, and sustaining closure actions.
Required Skills and Experience:
- Strong knowledge of industrial control systems (DCS & PLCs: ABB, Honeywell, Emerson, Yokogawa, etc.).
- Hands-on experience with OT (Operational Technology).
- Experience in Oil & Gas, Refinery, or Petrochemical environments.
- Experience in firewall review and access control systems.
- Proficient in risk assessment and developing operating procedures.
- Experience supporting audits and cybersecurity in control system environments.
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Summary:
Seeking an ICSR Lead Engineer with expertise in industrial control systems, OT cybersecurity, and risk management in Oil & Gas or Petrochemical industries. The role involves supporting maintenance, compliance, risk assessments, and cybersecurity improvement initiatives onsite in Houston, TX. Strong knowledge of DCS/PLC systems, firewall review, and audit support is essential. Contract and FTE opportunities available.