Training Manager, Lifecycle Safety
- Employer
- IQVIA
- Location
- Dublin
- Start date
- 24 Jul 2019
- Closing date
- 23 Aug 2019
View more
- Discipline
- Clinical Research, Pharmacovigilance
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Management
Job Details
TRAINING MANAGER- DUBLIN OR LISBON
HOME/OFFICE BASED- FULL TIME, PERMANENT
PURPOSE
The Training Manager, Lifecycle Safety, is primarily responsible for providing training across global Lifecycle Safety functions including ICSR case processing, Regulatory reporting, Medical Information, endpoint adjudication and aggregate reporting. The Training Manager will partner with Lifecycle Safety functional specialists and/or management to assess current training plans and processes looking to identify areas of improvement and delivery across different client projects.
RESPONSIBILITIES
Areas of responsibility include but are not limited to:
- Project Specific Training Plans:
- Collaborate with service leads to develop training plan requirements and roles
- Finalize training plan with agreements from designated IQVIA and Customer contacts
- Maintain real time ongoing agreements and updates to training plan
- Facilitate quarterly or annual training plan reviews as required on project
- Develop training slides and material independently or with service leads or designees
- Training Content:
- Set up eTraining folder and confirm role requirements for project
- Update / withdraw eTraining items in alignment with training plan updates
- Training Compliance:
- Plan and support development of Compliance reports
- Provide review and / or oversight of staff onboarding training compliance
- Provide review and / or oversight of monthly / quarterly training compliance data
- Participate, support or lead development of training plans, material or content for Departmental training needs.
- Participate, support or lead global initiatives to continuously improve training processes or compliance across LCS and their projects.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Sound working knowledge of medical terminology, clinical monitoring procedures (SOPs), ICH-GCP, applicable regulatory requirements, quality management processes
- Knowledge of National and International Regulations and Drug Development processes
- Knowledge of CRO or Pharmaceutical industry operations
- Knowledge of Quintiles corporate standards and SOPs
- Good organizational, interpersonal and communication skills
- Good judgement and decision-making skills
- Strong influencing and negotiation skills
- Strong computer skills including Microsoft Office and Clinical Trial Management System (CTMS) applications
- Demonstrated ability to work in a matrix environment
- Excellent problem-solving skills
- Ability to travel within the region/country
- Ability to lead and motivate a clinical team
- Ability to establish and maintain effective working relationships with co-workers, managers and clients/customers
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor's degree in life sciences or equivalent nursing qualification with a minimum of 6 years’ experience in Lifecycle Safety (Pharmacovigilance, CEVA, Medical Information, Safety Publishing, Risk Management, etc). Preferably with 2 of these years being in a related Training position.
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