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PV Operations Associate

at ICON Strategic Solutions in Little Rock, Arkansas, United States

Job Description

Overview

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Responsibilities

The Pharmacovigilance Associate will provide operational support to the Global Patient Safety (GPS) function, in accordance with the GPS vision, strategy and regulatory requirements.

· Regularly monitor and manage GPS mailboxes

· Communicate with safety vendor regarding individual case safety reports (ICSR).

· Assist with the reviews of ICSRs, listings, tables, and figures for completeness and quality as needed

· Assist with (serious) adverse event reconciliation of databases and listings (post marketing and clinical trial sources) as required

· Collaborate with internal teams (including clinical, medical, or regulatory) and external parties (including HCPs, consumers, or contracted resources) to obtain safety information

· Participate in and take minutes of meetings as required;

· Support the generation of aggregate safety reports

· Communicate with business partners or distributors regarding the receipt and transmission of safety information as per applicable safety data exchange agreements.

· Escalate any issues or concerns to GPS management as appropriate

· Perform all activities in compliance with applicable argenx Controlled Procedures and with global and local regulations as applicable.

Qualifications

+ Bachelor’s/Master’s degree in nursing, healthcare or other life-science or relevant technical field is required. Pharm D is preferred

+ 1-2 years of experience in pharmacovigilance/drug safety is preferred, (global experience is a plus)

+ Experience with adverse event collection and reporting

+ Demonstrated knowledge of pharmacovigilance regulatory requirements and guidelines

+ Experience with safety databases (e.g. ARGUS or ARISg) is a plus

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career – both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

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Posted Date 2 weeks ago (11/16/2022 6:59 PM)

ID 2022-96380

Location : Location US-Remote

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Job Posting: JC229160570

Posted On: Nov 23, 2022

Updated On: Dec 03, 2022

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