Pharmacovigilance PV Specialist - 1 year contract renewable
Pharmacovigilance PV Specialist - 1 year contract renewable
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Job Description
Job Summary
This role is responsible for the operational pharmacovigilance activities related to:
Case Intake and Triage include seriousness check Trilogy entry and case processer allocation.
Case submission to authorities including Clinical Trial Line Listing etc.
Case QC.
Followup Process.
Case Processing and Archiving.
Case Reconciliation.
Supports monthly metrics or case report analysis where appropriate.
Regulatory Intelligence Screening
Periodic Reports Scheduling and Reporting
Key Responsibilities :
Case Intake Triage Submission Followup and Reconciliation
Responsible for receiving/downloading information from Email/SharePoint/Efax 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 followup on safety reports if needed.
Check Case validity: Assess cases for missing information and follow up query requirements and initiate Followup (FU) Queries using the relevant letter and tracking followup attempts till the closure of followup.
QC case receipt and data entry.
Perform initial checks and search database to prevent duplicate entries.
Ensure upfront 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.
Backup for Case processing and followup.
Perform reconciliation and quality review.
Regulatory Intelligence Advocacy & NQPPV Strategy
Review and Approve ASEAN PV Hard Intelligence Monitoring Plan.
Updates AROS according to national legislation.
Supports Regulation Impact Assessment for potential trends and efficiencies implementation.
Supports NQPPV strategy according to local requirements and training.
Aggregate Safety Reporting (Periodic Safety Reporting Development Safety Reporting and Blinded SUSAR LineListing)
Assess the review of periodic safety update reports (PSURs) for a determined TA or product to obtain information on the risk/benefit profile of products and share with relevant stakeholders (i.e. ARMT etc.)
Supports the preparation of local periodic safety reports (if required) and ensures alignment and documentation of responsibilities between PPS RA and Affiliate PV.
Review global aggregate report schedule.
PV Partnership
Supports timely implementation/ update of LocalSafety Data Exchange Agreements (SDEA)/ PVService Provider Agreement/Preparation of contract fornonAbbVie QPPVs.
Supports endtoend process from establishing the PV Partnership Management and oversight of the partnership and closing out the PV Partnership.
Qualifications :
Education and Experience
Graduate in Pharmacy or LifeScience and/or proof of equivalent professional experience in drug safety (>2 yrs).
Strong preference of 3 year of pharmacovigilance or relevant clinical experience
Essential Skills Experience and Competencies
Fluency in written and oral English isessentialtofacilitate communicationswith relevant stakeholders.
Strong commitment to compliance with the relevant rules and procedures and to scientific quality and integrity.
Sound judgment strong planning and organizational skills and the ability to get things done. Demonstrated strong sense of urgency.
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.
US & Puerto Rico only to learn more visit ;
US & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.
US & Puerto Rico only to learn more visit ;
US & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
