Drug Safety Coordinator – Training

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.

The Role

This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. This role in particular supports both our Pharmacovigilance and Safety Services (PVSS) & Safety Reporting Group (SRG) teams in training activities, as well as supporting with related SOP and quality aspects as needed and in accordance with ICON standards, ICH/GCP/GVP, regulatory requirements, and local regulations and guidelines.

Responsibilities

As a quality and training advisor at the Drug Safety Coordinator (DSC) level, you will oversee and contribute to:

• Delivery and/or coordination of Instructor Led Training (ILT) Courses
• Developing new ILT or online learning (OLL) training courses alongside assigned pharmacovigilance SMEs
• Maintenance (including review) of existing PVSS courses, including knowledge assessments
• Acting as SME for pharmacovigilance training during audits and inspections
• Supporting the maintenance of the company Departmental and Functional Role Learning Plans for pharmacovigilance roles
• Scheduling training courses in the company Learning Management System (LMS)
• Representation of the pharmacovigilance training team on various cross-departmental initiatives / projects
• Provide training support to the pharmacovigilance business unit by answering questions or providing advice

Requirements

The successful candidate will have Industry experience (CRO or pharmaceutical) and knowledge in Pharmacovigilance and the regulatory environment governing safety and risk management activities.

• Minimum 5 years’ experience in Pharmacovigilance/Patient Safety
• A passion for training and helping individuals to develop skills and gain the necessary knowledge to succeed
• Experience with using Safety Database Systems (Argus preferred)
• Experience in the design, delivery, and evaluation of training courses or programs preferred, but not essential.
• Thorough knowledge of global safety processes/regulations and medical terminology/coding systems.
• Comprehensive knowledge of ICH-GCP, regulatory requirements which impact company policies, directives, and procedures
• Good knowledge of the drug, biologics, and device clinical trial development processes development processes, regulation awareness and scientific terminology
• Excellent organizational skills, along with being logical, systematic and curious; must be able to gather and interpret relevant information; must be able to work in a high volume and strict deadline environment
• Ability and comfort with speaking in front of large audiences via teleconference, web conferencing or face to face meetings
• Demonstrated experience and ability to develop comprehensive policy and procedure documentation in accordance with regulations
• Excellent writing, editing, proofreading, and process mapping skills
• Excellent written and verbal communication skills, with the ability to communicate and interact effectively with all levels of personnel.
• Proficiency in MS Word, Excel, PowerPoint, Outlook, and other software applications, such as Visio and Adobe Acrobat Pro
• Effective decision-making skills, sound judgement, and strong technical aptitude.
• Strong organization and analytical skills, with strong attention to detail.
• Strong self-starter and self-motivator, with the ability to work autonomously as well as enjoying working in a small team environment.
• Must be fluent in written and verbal English.

Medical/science background (nursing preferred) and/or bachelor’s degree or local equivalent

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 through the form below.