Pharmacovigilance (PV) Specialist - (1 year contract, renewable)

AbbVie (Thailand) (Bangkok, Bangkok City, Thailand)

Bangkok, Thailand

AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first — for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuroscience, eye care, aesthetics and other areas of unmet need.

Detail posisi

This role is responsible for the operational pharmacovigilance activities related to case intake, submission, follow-up, and reconciliation.

Kewajiban

Key Responsibilities :Case Intake, Triage, Submission, Follow-up and Reconciliation
• Responsible for receiving/downloading information from Email/SharePoint/E-fax, and receiving voice calls for reporting safety information.
• Route information/safety reports to appropriate AbbVie departments (e.g., Medical Information, Quality Assurance) as applicable.
• Monitor mailbox, and triage safety reports and emails.
• Maintain and archive emails/source documents and update SharePoint/folders.
• Handle source documents and enter data in the AbbVie tracking system as per triage criteria. Acknowledge receipt of information when needed.
• Obtain consent from the reporter to follow-up on safety reports if needed.
• Check Case validity: Assess cases for missing information and follow up query requirements and initiate Follow-up (FU) 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, and search database to prevent duplicate entries.
• Ensure up-front clarification requests in case of data discrepancy identified in source documents.
• 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 discrepancies and maintain email clarifications of discrepancies for SDV.
• Perform Health Authority extraction to retrieve ICSRs which are directly submitted to Health Authority when applicable.
• Check case types and assess cases for submission as per local and global regulatory guidelines.
• Submit ICSR to RA, Investigators, and EC.
• Translation, back translation and vendor translation QC of patient safety reports.
• Document review processes.
• Work with functional leads to improve case quality.
• Assists in the training and mentorship of new joiners as necessary.
• Back-up for Case processing and follow-up.
• Perform reconciliation and quality review.

Kualifikasi

• Relevant degree in life sciences or related field.
• Experience in pharmacovigilance or related area.
• Strong attention to detail and organizational skills.
• Excellent communication skills, both written and verbal.
• Ability to work independently and as part of a team.
• Proficiency in relevant software and databases.