Job Title: Pharmacovigilance Case Manager
Primary Responsibility
The Pharmacovigilance Case Manager will ensure that Individual Case Safety Reports (ICSRs) are processed and managed in compliance with regulatory requirements, company procedures, and pharmacovigilance agreements. This includes both local, regional, and global case processing activities.
Key Responsibilities:
Inbound & Outbound ICSR Case Management:
Case Handling:
Receive, assess, and process safety information from various sources, including healthcare providers, patients, and literature.
Enter safety data into the Global Inbound Receipt System (GIRS).
Ensure the timely reporting of safety information to partners.
Perform data entry for complex cases and follow up with additional information as needed.
Assist in the quality review and translation of safety information.
Regulatory Reporting:
Monitor and report ICSRs to Competent Authorities (CAs) or Business Partners (BPs) in a timely manner.
Support the oversight of Local Safety Officer (LSO) activities and escalate non-conformance issues.
Liaise with stakeholders for case processing requirements.
Other Activities:
Vendor and Cross-Country Support:
Provide support for vendor training, case review, and oversight.
Conduct screenings of local literature for ICSRs and safety signals.
Participate in periodic reconciliation activities.
Respond to ad hoc requests and support the roll-out of innovations.
Coordinate cross-country case management activities.
Documentation & Mentorship:
Write or review procedural documents.
Mentor junior staff and conduct quality checks on their work.
Lead or support critical projects related to pharmacovigilance.
Education & Experience Requirements:
Educational Qualifications:
A degree in life sciences, health sciences, or pharmaceutical sciences (e.g., Pharmacist, Medical Doctor, Biologist).
Experience:
Experience in pharmacovigilance or clinical safety preferred.
Essential Knowledge & Skills:
Medical Knowledge:
Knowledge of general medicine, pharmacy, and clinical practice with proficiency in medical terminology.
Understanding of pharmacovigilance legislation and ICSR-related procedures.
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 communicate effectively with stakeholders.
Company Overview:
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence, dedicated to accelerating the development and commercialization of innovative medical treatments. With a focus on improving patient outcomes and population health, IQVIA helps healthcare companies make intelligent, data-driven decisions.
Why IQVIA?
IQVIA is committed to fostering a diverse and inclusive workplace.
As an employee, you’ll be part of a global team that drives healthcare innovation and contributes to improving patient outcomes worldwide.
For more details and to apply, please visit: IQVIA Careers
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