Quality and Training Specialist
длъжност на пълно работно време

Quality and Training Specialist

Sofia длъжност на пълно работно време

За нас

We are vital links between an idea for new medicine and the people who need it. We are the people of PPD clinical research services — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.

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 the 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.

Изисквания и необходими умения

Key requirements

Either healthcare professionals or life science graduates
At a minimum bilingual and shall provide support in both their English and a Second European Langauge
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 in English and a 2nd European Language
Ability to work in a team environment and/or independently as needed

Ние Ви предлагаме

At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.

Our 4i Values:

Integrity – Innovation – Intensity – Involvement


If you are interested in learning more, please send your resume to alexander.bachev@ppd.com, and we’ll set up a time to connect!

As we are likely to receive many applications, sometimes we are unable to provide feedback to everyone.

Информация за контакт

Телефон: +359 2 8048805

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