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.