New
2 weeks ago
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Job Description/Requirements
Primary Responsibility
- Ensure ICSR case processing and related activities comply with regulatory requirements, company procedures, and PV agreements at local, regional, or global levels.
Inbound & Outbound ICSR Case Management
- Handle receipt, assessment, and processing of safety information from various sources.
- Enter safety data into the Global Inbound Receipt System (GIRS).
- Provide safety information to partners within timelines.
- Perform data entry for complex cases and follow-up for additional information.
- Assist in quality review and translation of safety information.
- Monitor and report ICSRs to Competent Authorities (CAs) or Business Partners (BPs).
- Support LSO oversight and escalate non-conformance.
- Liaise with stakeholders for case processing requirements.
Other Activities
- Support vendor training, case review, and oversight.
- Screen local literature for ICSRs and safety signals.
- Conduct periodic reconciliation activities.
- Respond to ad hoc requests and support innovation roll-out.
- Coordinate cross-country case management activities.
- Write or review procedural documents.
- Mentor junior staff and quality check their work.
- Lead or support critical projects.
Education & Experience Requirements
- Degree in life, health, or pharmaceutical sciences (e.g., Pharmacist, Medical Doctor, Biologist).
Essential Knowledge & Skills
- Knowledge of general medicine, pharmacy, or clinical practice; proficiency in medical terminology.
- Familiarity with ICSR-related PV procedural documents.
- Expert knowledge of GIRS and/or OST modules.
- Ability to prioritize and meet strict timelines.
- Excellent communication skills in local and English languages.
- Ability to negotiate and communicate with customers.
- Understanding of pharmacovigilance legislation.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
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