Medical Information Quality Officer - German Speaking

ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.

The Quality Officer will support the delivery of a high-quality medical information service by
assessing the quality of telephone skills and written work of others, maintaining compliance, and recording and quality approval of deviations, quality events, CAPA, effectiveness checks and change.

Essential Functions Include:

• Retrospective evaluation (quality check) of telephone calls, written correspondence, adverse event and product quality complaint reports of others within the company to ensure standards are met and maintained.
• Create reports and keep records from assessments.
• Create, review, analyse, and approve deviations, quality events, CAPA, effectiveness checks and change identified both internally and externally.
• Support ProPharma Group colleagues when audited by external clients or regulatory bodies, by creating reports, pulling documents, and supplying requested data.
• Support the Quality Manager in maintaining compliance of records within the QMS (quality management system) of ProPharma Group.
• Complete requirements of internal processes and deadlines to adhere to internal and external KPIs (e.g. training compliance, deviation turnaround times, etc).
• Maintain awareness of, and ensure compliance with, the legal requirements and professional guidelines associated with the provision of medical information within the pharmaceutical and healthcare industries.
• Ensure that the Confidentiality Statement within the Contract of Employment is always adhered to in respect of the data and property of ProPharma Group and its clients.
• Ensuring that any confidential information or personal data related to ProPharma Group and its clients is managed in accordance with Data Privacy regulations as described in ProPharma Group Standard Operating Procedures (SOPs).
• Work in a professional manner at all times with clients, customers, team members and management.

Qualified candidates must have:

• Bilingual (German and English). German skills must be mother tongue level or equivalent.
• Degree an advantage in a technical or numerical subject, or any subject requiring accuracy.
• Minimum of 5 GCSEs including English and Maths or equivalent
• Experience of quality assurance or control preferably in a contact center or heavily regulated industry.
• Able to work within a team in an open and professional manner.
• Able to work with minimal supervision.
• Previous Quality Assurance or Control experience assessing telephone calls or written communications advantageous.
• Previous experience of audit advantageous.
• Experience of core QMS process an advantage (e.g. investigation, root cause analysis, CAPA, change management, data management, etc).
• Excellent written and verbal communication skills.
• Sound planning, prioritising, and organisational skills.
• Excellent accuracy and attention to detail.
• Ability to problem solve and assist with root cause analysis.
• Computer literacy; MS Office and eQMS an advantage.

All candidates must be legally eligible to work in the United Kingdom.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***