Work Schedule

Environmental Conditions

Job Description

Summarized Purpose:

Responsible for quality review activities for customer interactions and their associated documentation managed by the Client’s intake team and assists with corrective action plans if needed. Performs reconciliation activities if required for the program. Delivers training when required and promotes continuous improvement. Supports the client with ensuring compliance with their policies and procedures and applicable health authority regulations (e.g., FDA, EMA), as well as standard inquiry management and documentation practices. May serve as a liaison with the clients for quality or training topics.

Essential Functions and Other Job Information:

Conducts quality control review of the required inquiries for accuracy, including details regarding the inquiry and resolution, as well as the accurate classification of each case.

Performs quality control for the compliance with required timelines for reportable events (adverse events/product quality complaints) as per the procedural documentation.

Performs a check for missed adverse events and product quality complaints.

Performs pharmacovigilance activities, such as but not limited to validation of safety and product quality complaint cases and reconciliation through generating reports and reviewing the correctness of the entries.

Delivers training courses and content for all staff members (incl. new hires) when required.

Observes training sessions and provides feedback regarding the effectiveness of training. Supports modifying training to increase beneficial outcomes.

Helps maintaining program’s training documentation in audit-ready status.

Evaluates quality trends across the program and provides feedback and suggestions to the management team. Propose and may develop continuous improvement initiatives based on gaps and trends identified.

Communicates with internal and external cross-functional departments to ensure deadlines are met.

Provides support for program-related audits.

May assist with departmental projects.

Qualifications:

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).

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