Ready to make a direct impact on patient safety in China and beyond? As an ICSR Submission Specialist, you'll be the driving force behind the timely and accurate submission of individual case safety reports (ICSRs) to the China health authority and other local regulatory bodies. You'll ensure adherence to the highest quality standards, regulatory guidelines, and internal processes, playing a vital role in pharmacovigilance.

Job Responsibilities: -

• Manage end-to-end ICSR submissions for China, guaranteeing compliant and timely filings.
• Handle local case reporting and E2B activities, including creating and distributing safety reports (CIOMS/MedWatch) and managing documentation.
• Engage with internal and external stakeholders for seamless information exchange and issue resolution.
• Identify and escalate unresolved issues promptly according to established processes.
• Monitor and prioritize reports for timely processing and distribution.
• Assess the reportability of safety information, staying updated on regulations.
• Perform or request causality assessments as required.
• Manage the accurate translation of necessary documents.
• Review scheduled reports in the safety system, verifying accuracy against guidelines.
• Mark reports for non-submission when appropriate and track them to successful acknowledgement.
• Maintain precise submission tracking data for local and foreign reports.
• Conduct reconciliation, documenting and tracking compliance data, including detailed records of case submissions and their status.
• Coordinate with local affiliates for timely submissions to regional authorities.
• Ensure accurate entry and updates of submission dates in relevant databases.
• Investigate, obtain, and update reasons for late submissions.
• Participate in regulatory intelligence activities.
• Confirm that reporting rules are correctly configured and functioning.
• Adhere to global and local procedures and guidelines.
• Provide training and mentorship to new team members.
• Manage submission-related mailboxes effectively.

Job Requirements: -

• Degree in Pharmacy, Life Sciences and related fields.
• Min 3 years of related working experience in regulatory affairs within Pharma and Biotech industry
• Strong communication skills ideally gained in a high-volume environment
• Excellent attention to detail and the ability to prioritize and work under a tight schedule and pressure
• Ability to adapt to a wide range of work procedure and operational guidelines
• Excellent communication skills especially Mandarin as you will need to liaise with China counterpart.
• Proficient in using Microsoft Word, Excel and PowerPoint

Interested candidates may apply through the application system or send to pekoh@morganmckinely.com. Shortlisted candidates will be notified.

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