Job Description

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.

Purpose:

This position is accountable for executing the day-to-day operations and compliance activities to maintain highfunctioning

PV systems across assigned region remit. Reports directly to PV Operational Team Lead OR Regional PV

Lead.


Metrics and Oversight of the Pharmacovigilance System

Supports the provision of metrics that will ensure oversight of all aspects of the performance and

functioning of the PV system in compliance with local regulations and internal company

timelines/standards.

For individuals acting as National QPPV / back up National QPPV, as per country attestation form:

Maintains oversight of AbbVie's PV system master file (PSMF) with the authority to ensure that the

information contained is an accurate and up-to-date reflection of the PV system.

Delegates specific tasks under supervision and with documentation, to appropriately qualified and

trained individuals, provided that the QPPV maintains system oversight and overview of the safety

profiles of all products.
Quality Management System

Develops and maintains local/regional procedures in line with corporate procedures and local

requirements.

Performs the impact assessment of new/updated corporate policies, process, and procedures. Actively assists with the PV Exception Reporting/CAPA process. Actively assists with the business continuity plan and testing. Develops and maintains the local PSMF in line with AbbVie's PV system master file, when required

by local/regional regulations
ICSR Management

Records, processes, and conducts follow up and translates adverse events and other safety

information from spontaneous and solicited sources.

Performs ICSR expedited reporting according to the local requirements. Ensures local-language medical or scientific literature review. Implements an appropriate local quality control (QC) procedure to ensure quality of information

entered and reporting decisions.

Completes AE reconciliation and ensures AE identification effectiveness sampling consistent with

global procedures.
Periodic Safety Reporting

Leads the preparation of periodic safety reports (e.g., PSUR)., local annexes, local variations, and

translation of safety deliverable documents.

Ensures submission of periodic safety reports and ensures documentation of evidence.

Audits and Inspection Management

Actively assists in managing internal PV audits, audits of affiliate service providers/third parties and

Regulatory Authority PV Inspections.

Actively assists in the development of CAPA in response to observations and the tracking actions to

completion in a timely manner.
Partnership with business partner with possibility for identification and/or handling of safety

information

Ensures all PV requirements are in place for activities where there is a reasonable possibility for the

identification and/or handling of safety information in accordance with AbbVie procedures and local

requirements.

PV Training

Ensures overall training compliance with corporate procedures and local PV requirements, including

the maintenance of the PV Training Matrix and the development of additional PV training materials,

as required.

Legislation Intelligence

Monitors local (and applicable regional/area) PV-relevant hard intelligence, leading the impact

assessment of them.
Risk Management

For Individuals supporting Risk Management activities:

Coordinates the receipt and distribution of RMP, Core Implementation Plan (CIP) and additional risk

minimization measures (aRMM) to affiliate stakeholders.

Develops a deep knowledge of the Risk Management Plans (RMPs) to obtain information on the

risk/benefit profile of products.

Liaises with affiliate stakeholders & Benefit Risk Management (BRM) Team and where applicable,

seek involvement of relevant PSEQ stakeholders during development or revision of the COUNTRY

Specific Annex (if applicable), Local Implementation Plan (LIP) & local aRMMPerforms the assessment and implementation of the CIP and accompanying aRMM,

when applicable

For individuals acting as National QPPV / back up National QPPV:

Develops a deep knowledge of the RMPs to obtain information on the benefit/risk profile of

products.

Performs the assessment and implementation of the CIS and accompanying aRMM, when

applicable.
Safety Monitoring

For Individuals supporting Safety Monitoring activities

Understands and monitors incoming local safety data and communicate changes or potential

concerns to the PSEQ Product Safety Team Lead and the EU QPPV (for products marketed in the

EEA), for evaluation.

After Hours Availability & Business Continuity

For individuals acting as National QPPV / back up National QPPV, as per country attestation form:

Ensures availability to be at AbbVie's disposal permanently and continuously on a 24-hour basis, if

applicable, and that an after-hours process is in place for the reporting of AEs and that a Disaster

Recovery Plan/Business Continuity Plan is established to allow for continuation of critical business

processes for PV.

Qualifications

A minimum of 2 years' experience required within the pharmacovigilance or a related field Effective communicator and able to work effectively in teams and a cross functional environment. Strong commitment to compliance with relevant rules and procedures. Effective planning and organizational skills, and the ability to complete activities with high quality.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.


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