Responsibilites:
- Responsible for receiving / downloading information from Email/SharePoint/E-fax, receiving voice calls for reporting safety information
- Route information/safety reports to appropriate department (e.g. Medical Information, Quality Assurance) as applicable.
- Monitor mailbox; triage safety reports and emails.
- Maintain and archive emails/source documents and update SharePoint/folders.
- Handle source documents and enter data in tracking system as per triage criteria.
- Acknowledge receipt of information when needed.
- Obtain consent from reporter to FU on safety reports if needed.
- Check Case validity: assess cases for missing information and follow up query requirement and initiate Follow up Queries using the relevant letter and tracking follow up attempts till the closure of follow up.
- QC case receipt and data entry.
- Perform initial checks, search database to prevent duplicate entries.
- Ensure up front clarification requests in case of data discrepancy identified in source document/s.
- Evaluate the safety information for case seriousness and including potential for upgrade /downgrade of FU cases.
- Responsible for receiving, reviewing, and archiving source data records for any missing/discrepant safety information Identify discrepancy/ies and maintain email clarifications of discrepancies for SDV.
- Perform Health Authority extraction to retrieve ICSRs which are directly submitted to Health Authority when applicable.
- Submit ICSR to RA, Investigators and EC.
- Translation, back translation & vendor translation QC of patient safety reports.
- Document review processes
- Work with functional lead to improve case quality.
- Process cases
- Check case type and assess cases for submission as per local and global regulatory guidelines.
- Case QC process.
- Back-up for Case Intake, triage and submission.
- Perform reconciliation and quality review.
- Ensuring vendor assessment, training and communication.
- Respond to regulatory authority individual case request.
- Performs ICSR Hard Intelligence related Impact Assessment and implements required changes.
- Keeps oversight of the Literature screening process and vendor.
Requirements:
- Min. Degree in Pharmacy or Lifescience or any relevant field
- Min3- 5 years prior working experience in Drug Safety Management
- Excellent interpersonal and communtication skills
- Team player and able to work independently as well
Interested candidates please send your updated resume to:
[email protected]
Attn: Drug Safety Specialist (Pharma MNC, West) #HKA
or call 6736 3280 to look for Kayley
We regret to inform that only shortlisted candidates will be contacted
EA Personnel: Kayley Ng Yin Yi (R1762843)
Company EA Registration Number: Recruit Express Pte Ltd (99C4599)
