Drug Safety Coordinator

"At ICON, it's our People that set us Apart"

ICON plc, a leading global Contract Research Organization employing 15,000 people in 40 countries. ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.

About the Drug Safety Coordinator at ICON:

* Serve as support to Medical & Safety Services management in all aspects of departmental activities, as needed
* Serve as technical expert with regard to all aspects of safety monitoring
* Ensure that daily project safety activities are completed in accordance with ICON standards and other applicable standards
* Ensure all ICON, Sponsor, and regulatory timeframes are met for the processing and reporting of safety information

Responsibilities include:

Planning solutions to achieve identified objectives, developing controlled documents where appropriate, interfacing with senior cross-functional leaders, and influencing decision-making in aspect of operational oversight.

Assist PV leadership with activities related to operations, regulatory inspections and audits Collaborate with project manager and contribute to the Pharmacovigilance System Master File (PSMF) as applicable

Assist in providing leadership, as applicable, supporting in daily functional oversight tasks and responsibilities. Development and maintenance of PV SOPs and Work Instructions, working closely with PV colleagues and Quality Assurance to ensure compliance with applicable global PV legislation and guidance.

Maintain inspection readiness Manage the day to day activities and participate in the daily functional activities as and when required Execute oversight responsibilities as defined and documented in the applicable SOPs and associated work instructions Coordinate and participate in governance activities as required.

Review/analysis of team workload distribution Complete issue identification and resolution Track, document and archive the oversight activities in an inspection ready format

Skills Required:

7+ years of experience for DSC & Postmarketing case processing experience

- Eye for detail for quality and timeline metrics

-should be able to lead a team

-should be adaptable for changes to accommodate the business requirement

-should be able to proactively analyze and communicate the risks to project manager before they turn out to be an issue

-should be able to mentor and train new team members

- knowledge regarding inspections and audit is must

-Experience in Quality review of ICSR cases

-Hands on global safety database experience (preferably ARGUS) with significant experience in case quality control and managing and tracking of case workload

-Ability to work independently

-Strong communication skills (written and oral), interpersonal, organizational and cross-functional collaboration skills

- Project management knowledge is added value

Benefits of working at ICON:

ICON offers an exceptional benefits package that includes a comprehensive health plan, retirement plans, highly competitive pay, corporate bonus plan, time away from work, and other incentives. We provide you with the technology, innovation and resources to be successful in ensuring utmost compliance and operational efficiencies

What's Next?

Following your application if you are successful you will be invited to an initial telephone interview with one of our dedicated recruiters who will be able to provide you with more details of this opportunity.

We invite you to review our opportunities at www.iconplc.com/careers.