Position Summary:
Responsible for managing Individual Case Safety Reports (ICSRs) and related pharmacovigilance activities to ensure compliance with global, regional, and local regulatory requirements for Singapore and Philippines, with potential support for other countries. This role includes oversight of vendors, cross-country collaboration, and continuous process improvement.
Principal Responsibilities:
INBOUND & OUTBOUND ICSR CASE MANAGEMENT:
- Monitor reportability and submit ICSRs to Competent Authorities and Business Partners within timelines.
- Receipt, assessment, and processing of incoming safety information from multiple sources, both internal and external to the Company.
- Enter relevant/required safety data into the Global Inbound Receipt System (GIRS) from spontaneous, clinical trials and other solicited sources.
- Provision of safety information/acknowledgements to marketing partners/other third-party partners/Global Medical Safety within the internal and contractual timelines.
- Data entry for complex cases
- Performing follow-up requests for additional information from multiple sources.
- Assist in the quality review of data captured in the GIRS as applicable
- Verify and ensure translation of safety information, if applicable.
- Enable mechanisms to support LSO oversight for case management activities as applicable. e.g. escalation non-conformance in a timely manner.
Vendor Management & Oversight:
- Manage vendor relationships for case processing activities, ensuring adherence to contractual and quality standards.
- Conduct vendor training and provide ongoing support at case level.
- Perform daily or periodic vendor oversight, including case reviews and compliance checks.
- Collaborate with vendors to resolve issues and implement process improvements.
- Compliance & Quality Oversight
- Ensure accurate and timely documentation of deviations, root cause analysis, and CAPAs.
- Support LSO in reviewing new/revised PV regulations and assess impact on local processes.
OTHER ACTIVITIES:
- Ensure and support other case management related activities such as vendor training, on-going vendor support on a case level (daily or as required), case review, and vendor oversight (daily or as required)
- Local literature screening for ICSRs and potential safety signals (in consultation with local medical safety as needed).
- Periodic reconciliation activities
- Support LSO in responding to ad hoc requests (e.g. regulatory authority requests) as required.
- Lead or support case management related innovation roll-out, in collaboration with the LMS Case Management Regional and Team leads
- Lead or support the coordination and process standardization efforts to cross-country collaboration with regards to case management activities, as applicable
- Write or review ICSR related procedural documents and local memo implementation as applicable.
- Act as a mentor to junior staff and quality checking their work
- Lead or support critical project works
Qualifications:
- Degree in Life Sciences, Pharmacy, or Medicine (preferred).
- 35 years experience in pharmaceutical pharmacovigilance / drug safety.
- Strong expertise in ICSR processing, drug safety compliance, and regulatory reporting.
- Experience with pharma regulatory submissions in Singapore and/or the Philippines, including clinical trial safety cases.
- Good knowledge of global and local PV / drug safety regulations.
- Familiarity with PV systems (e.g., GIRS, OST).
- Experience in vendor oversight and cross-country pharma collaboration.
- Fluent in English.
