Ensuring Individual Case Safety Report (ICSR) case processing and related activities are carried out to enable compliance with applicable regulatory requirements, company procedures, at a local/regional level or global level, and in compliance with provisions of PV agreements with business partners.

• The scope of support is primarily focused on countries. The role holder may be expected to support and ensure case management and related activities for other countries within the APAC Region (centralized case management) are carried out in a timely manner.

• Conducted literature searches and evaluated scientific articles for potential safety signals

• Maintained and updated safety information in the company's database.

• Collaborated with cross-functional teams such as clinical research, medical affairs, and regulatory affairs to

ensure timely and effective reporting of adverse events.

• Maintained accurate and up-to-date records of adverse event data using company database.

• Assessed the potential causality of adverse events and documented conclusions in individual case safety

  reports.

PRINCIPAL RESPONSIBILITIES:

• Inbound & Outbound ICSR Case Management

• Performs Follow Up on cases according to the procedures of organization

• Identify the clinically relevant information missing from the case reports and facilitate its

collection.

• Perform case safety data correction.

• Regulatory Compliance Monitoring

• Local literature screening for ICSRs and potential safety signals (in consultation

with local medical safety as needed)

• Periodic reconciliation activity.