Job Title: Pharmacovigilance Case Manager
Primary Responsibility:
Ensure ICSR (Individual Case Safety Report) case processing and related activities comply with regulatory requirements, company procedures, and pharmacovigilance (PV) agreements at local, regional, or global levels.
Key Responsibilities:
Inbound & Outbound ICSR Case Management:
Case Handling:
Receive, assess, and process safety information from various sources.
Enter safety data into the Global Inbound Receipt System (GIRS).
Provide safety information to partners within established timelines.
Perform data entry for complex cases and follow up for additional information as necessary.
Assist in quality review and translation of safety data as required.
Regulatory Reporting:
Monitor and report ICSRs to Competent Authorities (CAs) and Business Partners (BPs).
Support Local Safety Officer (LSO) oversight and escalate non-conformance issues as needed.
Liaise with stakeholders to ensure proper case processing and compliance with regulations.
Additional Activities:
Vendor & Cross-Country Support:
Support vendor training, case review, and oversight to ensure compliance with safety reporting standards.
Screen local literature for ICSRs and safety signals.
Conduct periodic reconciliation activities.
Respond to ad hoc requests and support the rollout of innovative pharmacovigilance initiatives.
Coordinate cross-country case management activities and case follow-ups.
Documentation & Leadership:
Write or review procedural documents related to case management and pharmacovigilance activities.
Mentor junior staff, quality check their work, and ensure compliance with internal standards.
Lead or support critical pharmacovigilance projects.
Education & Experience Requirements:
Educational Qualifications:
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 general medicine, pharmacy, and clinical practice; familiarity with medical terminology.
Familiarity with ICSR-related pharmacovigilance procedural documents.
Technical Skills:
Expert knowledge of GIRS and/or OST modules for case management and reporting.
Communication & Time Management:
Ability to prioritize and meet strict timelines in a fast-paced environment.
Excellent communication skills in both local and English languages.
Ability to negotiate and communicate effectively with internal and external stakeholders.
Regulatory Knowledge:
Strong understanding of pharmacovigilance legislation and ICSR reporting requirements.
About IQVIA:
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 innovative medical treatments to improve patient outcomes and population health.
For more details and to apply, visit IQVIA Careers.
Apply Now
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