PRA Health Sciences

Director of Quality & Training Development Pharmacovigilance & Patient Safety

3 days left

Location
United Kingdom or Germany
Salary
competative
Posted
29 Jan 2021
Closes
28 Feb 2021
Ref
ABR 2021-72470
Hours
Full Time
Contract Type
Permanent
Experience Level
Director/Executive

The Director of Training & Compliance is involved in or fully responsible for directing the training and quality/compliance efforts for Pharmacovigilance & Patient Safety (PVS).

They are responsible for working with management to ensure effective quality oversight and training activities occur for PVS programs, as well as providing ongoing feedback related to quality of services and compliance with regulatory guidelines with critical attention to addressing issues with solution-oriented proposals.

Further responsibilities are: 

  • Develop and continually improve quality control measures and assessments for PVS services, including standard quality checks
  • Conduct quality control activities on selected service areas as needed; conduct trending analyses and report results to PVS management team
    • Analyze qualitatively and quantitatively data collected through QC activities and identify areas of potential training needs
    • Analyze gaps and weakness in the processes describing PVS services
  • Develop, continuously improve and implement training ensuring compliance with processes executed by PVS staff
    • Develop training content by involving subject matter experts (SME) as appropriate
    • In cooperation with the assigned Instructional Designer, decide upon the best training delivery method
    • Oversee training material finalization
    • For instructor led training: Train and mentor trainers responsible for delivery of the new/revised training (train-the-trainer)
    • Collect and evaluate feedback to training course and material and improve training courses/material accordingly
    • Ensures that training activities are designed and delivered on time, within budget, and according to business unit leader requirements.
    • In cooperation with the Director of Safety Regulatory Intelligence, develop, and continually improve training on new Pharmacovigilance regulations
    • Develop, coordinate, and host regular continuing education and development opportunities for PVS staff
    • Deliver high quality training activities for PVS staff.
  • In cooperation with the director responsible for the PVS department, prepare job/role specific curricula
    • for new hires
    • for continuing development in each job/role
    • for task specific training
    • Upon request, advises functional managers on the development of individual training plans
  • Lead activities related to development and improvement of PVS and Patient Safety controlled documents including, but not limited to SOPs, work instructions and associated documents.
    • Develop, maintain, distribute, and continually improve tools (e.g. Quick Reference Guides, Checklists, etc.) to improve field staff efficiency or compliance
  • Provides Pharmacovigilance expertise and training to other PRA personnel, as appropriate
  • Supports the inspection and audit management process, including:
    • Supporting the PVS team in preparing for internal and external audits and inspections
    • Supporting audit finding responses
    • Periodic assessment of open audit findings and follow up until closure
  • Supports billable projects through activities such as:
    • Drafting and/or maintaining a Quality & Training Plan for an assigned program
    • In collaboration with senior department management and program leadership ensures effective Quality & Training Plan(s) are in place and maintained for assigned programs
    • Being assigned to programs and attending governance meetings
  • Leads a team of Trainers
  • Consult directly with PVS leadership on Quality and Training needs

Location: The role can be office-based or remote in the United Kingdom or Germany.

You have: 

  • An undergraduate degree or its international equivalent from an accredited institution. Focus area in in clinical, science, or health-related field, preferred.
  • An advanced degree in education, organizational development, business, clinical, science or health-related or its international equivalent, preferred.
  • Minimum of 8 years of experience in Pharmacovigilance or related services and at least 5 years in a managerial role.
  • Broad and in depth pharmaceutical or contract research organization experience including project leadership and management of technical staff required
  • 5 years of experience in Training and/or Quality positions
  • Progressive experience in the design, delivery, and evaluation of training programs, preferred. Working knowledge of training management software, preferred.
  • Experience preparing, implementing, and managing department operating plans, budgets, and profitability preferred
  • Track record of implementing processes that assure compliance with regulatory submissions requirements for human drugs, biologics, and/or devices required
  • Strong knowledge relevant to ICH report writing guidelines, and regulatory submission requirements for human drugs
  • Skills with industry standard safety and clinical data bases.
  • Excellent written, oral communication and presentation skills
  • Read, write, and speak fluent English; fluent in host country language required.

Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better.

PRA Health Sciences is an Equal Opportunity Employer.  We welcome and encourage diversity in the workplace.

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