ICON Hiring Pharmacovigilance Trainer / PV trainer
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.
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
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