Job Description
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.
Apply via :
jobs.iqvia.com