Assistant Director, QA Pharmacovigilance Job in Abbott Park 60064, Illinois Us

Job Title: Assistant Director, QA Pharmacovigilance

Position Description

The Pharmacovigilance Compliance Function is responsible for ensuring compliance with worldwide regulatory requirements for all safety and pharmacovigilance activities, as well as pharmaceutical affiliates and Partner Companies that provide safety data for products.

Position Responsibilities

Responsible for implementing and maintaining the effectiveness of the quality system.
Assures that company is in a continuous state of PV compliance with policies and procedures and country specific and other applicable standards and worldwide regulations by continuously evaluating PV processes and actively participating in PV audit planning, conduct and resolution.
Collaborates with business partners and other GxP functions to support effective and timely solutions/responses to compliance issues/questions including audit/inspection findings.
Participates in the development and implementation of systems and processes required to support global audit processes and quality assurance requirements including management review and continuous improvement processes.
Actively participates in and supports PV inspections or remotely helps to make PV inspections a success and supports resolution of findings by working with PV business partners.
Promotes continuous education on PV regulations for self and other staff.
Ensures development / continuous improvement and implementation of necessary PV systems to ensure compliance to worldwide regulations and AQR policies.
Generates, analyzes and reports PV compliance metrics do demonstrate key aspects of the PV compliance status.
Demonstrates accountability and responsibility for Environmental Health and Safety (EHS) performance and compliance through active participation and support of EHS Programme.

Position Requirements

Responsible for global QA function within one discipline or multiple disciplines at one site. Balance complex resource needs across QA functions.
Responsible for contributing input into resource management of a function. Provide counsel, guidance, direction and motivation to quality assurance operations staff.
Emerging Leader in GPRD organization. Demonstrates strong leadership competencies. Makes decisions and charts course through careful evaluation of risks and benefits with limited information in conjunction with Director. Builds/drives relationships and teamwork within team and across functions with professional demeanor.
Multi year pharmaceutical experience in the fields of pharmacovigilance and quality assurance.
Ability to work at an experienced operations level.
Strong analytical skills and the ability to organize work in a logical, thorough and succinct manner.
Detailed knowledge of auditing standards.
Extensive knowledge of worldwide PV regulatory requirements and industry best practices.
Flexibility to adapt to changing assignments and ability to effectively prioritize.
Project management, interpersonal, and communication skills and ability to work independently and as part of a team.
Willingness and ability to perform international travel up to 40%.
Bachelor's Degree or equivalent +8 years of experience.
Percent of Travel 20 - 50 %

Benefits

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