PPD

Quality and Training Specialist with German/French and English- Sofia, Bulgaria

Company
PPD
Location
Sofia, Bulgaria
Salary
Competitive
Posted
05 Aug 2021
Closes
04 Sep 2021
Ref
1197732
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Summarized Purpose:

Oversees and coordinates quality and/or training programs and activities. Leads or performs quality reviews of customer interactions and associated documentation and coordinates and assists with corrective action plans if needed. Ensures program compliance with corporate, departmental and client policies and procedures including SOPs and applicable health authority regulations (e.g. FDA, EMEA), as well as standard inquiry management and documentation practices. May serve as a liaison with the clients for training or quality topics.

Essential responsibilities and key activities:
  • Conducts quality review and control of staff members' work and monitors accuracy and completeness of information provided, including clinical content. Such work includes:
    • Quality control on incoming Medical Information enquiry cases
    • Quality control of cases tagged as Medical Information Enquiry
    • Quality control of cases tagged as Safety reporting or Quality Complaint and routed to Safety/Quality department
  • Ensures program consistency relative to compliance with the organization and client policies/procedures.
  • Evaluates quality trends across the program and provides feedback and suggestions to the management team. Tracks and documents Quality Events. Develops continuous improvement initiatives based on gaps and trends identified.
  • Schedules, develops and delivers training courses and content for all staff members when required. Conducts product or disease state training for staff members as required.
  • Monitors effectiveness of training and observes training sessions, trends and assesses impact in employee performance. Modifies training to increase beneficial outcomes.
  • Integrates training with the client while negotiating organizational differences in culture, management structure and staffing. Liaises with the client, department management and staff for all training related topics. Maintains program training documentation in audit-ready status.
  • Provides support for program-related audits.
  • May assist with department projects.


Qualifications:

Key requirements:
  • Either healthcare professionals or life science graduates
  • At a minimum bilingual and shall provide support in both their target language (DE or FR) as well as English
  • 2+ years' experience as a contact center MIS or equivalent combination of education, training, and experience
  • Prior QTS experience preferred/will be considered an advantage


Knowledge, Skills and Abilities:
  • Strong understanding of applicable health authority (e.g. FDA, EMA) or local regulations
  • Good knowledge of drugs and drug information
  • Ability to perform call/document review, including complex clinical discussions and provide clear and concise feedback
  • Firm organizational and time management skills
  • Strong attention to detail and ability to multi-task
  • Strong verbal and written communication skills
  • Solid problem solving skills
  • Strong computer skills including Microsoft Office
  • Ability to train and mentor others
  • Excellent language skills (comprehension, speaking, reading and writing) must be demonstrated if the position requires languages other than English
  • Ability to work in a team environment and/or independently as needed