Pharmacovigilance Reporting Specialist
hace 1 semana
ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research by providing outsourced services to pharmaceutical, biotechnology, medical device, and government organizations.
We put our patients at the center of everything we do, accelerating the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength and the driving force behind our success. We have a mission to succeed and a passion that ensures what we do, we do well.
Responsibilities:
We are seeking an experienced Pharmacovigilance Reporting Specialist to join our team. In this role, you will be responsible for submitting expedited Serious Adverse Event (SAE) reports, Periodic reports, line listings, and applicable safety information to clients, regulatory authorities, ethics committees, investigators, third-party vendors, partners, and ICON personnel, as required and agreed upon with the client, within project-specified timelines.
You will also release safety reporting intelligence for expedited and periodic reports, line listings, for regulatory authorities, ethics committees, and investigators within specified timelines in accordance with company procedures.
To be successful in this role, you must maintain a strong understanding of ICON's safety reporting systems, processes, and conventions, as appropriate. You will also need to maintain a strong understanding of ICON Standard Operating Procedures (SOPs), Working Procedures (WPs), guidance documents, and manuals associated with safety reporting.
In addition, you will perform oversight of assigned projects to ensure all ICON, Sponsor, and regulatory timeframes are met for the reporting of safety information or for the release of global safety reporting intelligence requirements.
You will operate in a lead capacity, ensuring ownership and accountability of safety reporting activities or safety reporting intelligence on assigned projects. You will also ensure completion of all assigned project activities accurately and in accordance with ICON standards, regulatory requirements, and client contractual obligations.
Requirements:
We are looking for a highly motivated and detail-oriented individual with experience in the pharmacovigilance area. The ideal candidate will have at least 1 year of experience in the industry, excellent verbal and written communication skills, and the ability to work effectively independently and within a team environment.
The successful candidate will also have excellent organizational and time management skills, a strong understanding of applicable therapeutic areas and disease states, and the ability to maintain confidentiality and handle sensitive information.
About ICON:
At ICON, we offer a competitive salary package, including an estimated annual salary of $65,000 - $85,000, depending on location and experience. Our benefits include health-related benefits for employees and their families, competitive retirement plans, and related benefits such as life assurance.
We also provide a range of opportunities for professional development and growth, including training programs, mentorship, and career advancement opportunities.
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