PV Operational Associate

Purpose:

This position is accountable for executing the day-to-day operations and compliance activities to maintain high functioning
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 Abb Vie’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 Abb Vie’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 Abb Vie 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 aRMM

• Performs 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…