Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
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.
• Follow-up 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, 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.
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 Line-Listing)
• 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 Local Safety Data Exchange Agreements (SDEA)/ PV Service Provider Agreement/ Preparation of contract for non-AbbVie QPPVs.
• Supports end-to-end 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 Life-Science 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 is essential to facilitate communications with 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 AbbVie’s 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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
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 AbbVie’s 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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html