ICSR Management Specialist

Company Overview

Information about the company is currently unavailable.

Job Summary

The ICSR Management Specialist will be responsible for handling various aspects of Individual Case Safety Reports (ICSR) to ensure compliance and efficiency in pharmacovigilance processes. This role is crucial for the successful management and oversight of safety data throughout the lifecycle of programs and studies, contributing to the overall safety and quality assurance within the organization.

Responsibilities

• Configure Argus for new programs and studies, ensuring all necessary parameters are set for effective case management.
• Process ICSR efficiently, adhering to regulatory standards and internal procedures.
• Implement case processing coding conventions to maintain consistency and accuracy across reports.
• Interact with Local Operating Companies (LOC) to facilitate smooth communication and resolution of queries related to case handling.
• Oversee functional vendors involved in pharmacovigilance activities, ensuring adherence to quality and regulatory requirements.
• Manage new market authorizations and the withdrawal of market authorizations, communicating necessary information to all stakeholders.
• Promote PAC (Pharmacovigilance Awareness and Communication) within the organization.
• Engage in clinical trial interactions including study/program setup, maintenance, and closeout processes.

Qualifications

• Experience with Argus or similar pharmacovigilance databases.
• Understanding of ICSR processing and regulatory requirements.
• Familiarity with case processing coding conventions.
• Strong communication and interpersonal skills for effective interactions with LOCs and vendors.
• Detail-oriented with strong organizational skills for managing multiple studies/programs.
• Educational qualifications in Life Sciences, Pharmacy, or a related field (BSc, MSc, or equivalent).
• Knowledge of pharmacovigilance principles and practices.

Preferred Skills

• Prior experience in regulatory submissions to authorities, partners, clinical research organizations (CROs), and LOCs.
• Strong project management skills.
• Understanding of clinical operations processes and systems.

Experience

• A minimum of 3-5 years of experience in pharmacovigilance or ICSR management.
• Relevant experience in clinical trial management and interactions.

Environment

Details regarding the work setting, location, and physical conditions are currently unavailable.

Salary

Salary information is currently not provided.

Growth Opportunities

Information on career advancement opportunities is not available at this time.

Benefits

Details on offered benefits are currently not specified.