ICON Hiring Pharmacovigilance Trainer / PV trainer

Job Description

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 bachelors degree or local equivalent

Apply HERE