Job Title: Pharmacovigilance Case Manager
Primary Responsibility:
Ensure that Individual Case Safety Reports (ICSRs) and related activities comply with regulatory requirements, company procedures, and pharmacovigilance (PV) agreements at the local, regional, or global levels.
Key Responsibilities:
Inbound & Outbound ICSR Case Management:
Case Handling:
Handle receipt, assessment, and processing of safety information from various sources, including healthcare providers, patients, and literature.
Enter safety data into the Global Inbound Receipt System (GIRS).
Ensure timely provision of safety information to business partners (BPs) and competent authorities (CAs).
Perform data entry for complex cases and follow-up for additional information as necessary.
Assist in quality review and translation of safety information to ensure accuracy.
Regulatory Reporting:
Monitor and report ICSRs to Competent Authorities (CAs) and Business Partners (BPs) within specified timelines.
Support Local Safety Officer (LSO) oversight and escalate non-conformance cases as required.
Liaise with internal and external stakeholders to meet case processing requirements.
Additional Activities:
Vendor and Cross-Country Support:
Provide support for vendor training, case review, and oversight activities.
Screen local literature for ICSRs and safety signals.
Conduct periodic reconciliation activities to ensure data integrity.
Respond to ad hoc requests related to case management and pharmacovigilance processes.
Documentation and Leadership:
Write and review procedural documents for case management activities.
Mentor junior staff and perform quality checks on their work to ensure compliance with standards.
Lead or support critical projects related to pharmacovigilance activities.
Education & Experience Requirements:
Educational Qualifications:
A degree in life sciences, health sciences, or pharmaceutical sciences (e.g., Pharmacist, Medical Doctor, Biologist).
Experience:
Previous experience in pharmacovigilance or clinical safety is highly preferred.
Essential Knowledge & Skills:
Medical Knowledge:
Proficiency in medical terminology and knowledge of general medicine, pharmacy, and clinical practice.
Familiarity with ICSR-related pharmacovigilance procedural documents.
Technical Proficiency:
Expertise in using GIRS and/or OST modules for ICSR case management.
Time Management & Communication:
Ability to prioritize tasks, meet strict timelines, and manage competing demands.
Strong communication skills, both in the local language and English, with the ability to negotiate and collaborate effectively with internal and external stakeholders.
Regulatory Knowledge:
Understanding of pharmacovigilance legislation and regulations related to ICSR reporting.
Company Overview:
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence, helping life sciences and healthcare industries accelerate the development and commercialization of medical treatments to improve patient outcomes and public health.
For more details and to apply, please visit IQVIA Careers.
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