Specialist, Pharmacovigilance

Company Description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

Purpose

Describe the primary goals, objectives or functions or outputs of this position.

The purpose of this role is to execute 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.

Responsibilities

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

Quality 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 local PV Exception Reporting/ corrective and preventive actions (CAPA) process.

Actively assists with the business continuity plan and testing.

Metrics and Oversight

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, internal company timelines/standards.

ICSR Management

Supports regional ICSR management as needed, ensuring ICSR compliance with required timelines and standards.

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.

Qualifications

Qualifications

List required and preferred qualifications (up to 10). Include education, skills and experience.

Bachelor's degree in health/science discipline.

A minimum of 2-3 years’ experience required within the pharmacovigilance field including extensive experience in overseeing PV operational and compliance metrics. Working experience within pharmaceutical industry, in particular pharmacovigilance is preferred.

Professional experience in disease management in a patient/health related field preferred.

Effective communicator and able to work effectively in teams and a cross functional environment Computer proficient with Microsoft programs particularly Word, PowerPoint and Excel.

Effective follow through on execution of daily tasks and management of responsibilities Ability to perform teamwork.

Additional Information

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

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