Compliance Specialist, QPPV Office - Pharmacosmos

Compliance Specialist, QPPV Office
Join our QPPV Office as a Senior Specialist in Drug Safety, ensuring compliance and driving improvements with a dedicated team of professionals.

Job openings

Deadline

October 31, 2024

Department

Drug Safety

Apply via Compass

As a Senior Specialist in the QPPV Office, you will join the Drug Safety organization, working with experienced and dedicated colleagues. You will be part of a small team in the QPPV Office, coordinating inputs from international partners and affiliates, managing PSMF updates, and driving improvements in Drug Safety. Your responsibilities will include ensuring compliance with Good Pharmacovigilance Practices (GVP) and maintaining quality systems that ensure the safety and efficacy of pharmaceutical products.

Key responsibilities

• Secure input and updates to the Pharmacovigilance System Master Files (PSMFs).
• Ensure compliance with international regulations, including GVP, ICH (International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and local requirements.
• Collaborate with cross-functional teams, such as Regulatory Affairs (RA), Quality Assurance (QA), and Pharmacovigilance (PV), to foster continuous improvement.
• Contribute to the management and maintenance of the Quality Management System (QMS) for the Global Drug Safety department.
• Participate in hosting PV audits and inspections conducted by clients and regulatory authorities.
• Manage Corrective and Preventive Action (CAPA) processes to address and resolve quality-related issues.
• Oversee the implementation and updating of training programs for the Global Drug Safety department.
• Ensure proper Key Performance Indicator (KPI) oversight – collection of datapoints and reporting.

Ideal fit – qualifications and experience
This role is ideal for you if you are passionate about structure and processes, enjoy supporting others, and appreciate a positive work environment. You’ll join a supportive team that values both productivity and camaraderie, ensuring that while important work gets done, there’s always room for laughs and a bit of fun along the way. In addition, we expect you to be independent and able to take initiative, bringing a proactive mindset to your tasks. A relevant educational background and experience are also essential.

• A degree in life sciences, quality management, or a related field.
• Relevant experience in the pharmaceutical industry, ideally within QPPV Office tasks, drug safety, regulatory affairs, or quality management.
• Strong knowledge of global pharmaceutical regulations and guidelines (e.g. EMA, MHRA, FDA, NMPA og ICH).
• Excellent organizational skills, with the ability to manage multiple tasks and meet deadlines.
• Strong communication and collaboration skills across departments.
• Great overview and detail-oriented.
• Fluency in English, both written and spoken.

Strong entrepreneurial culture
You will experience a company defined by an entrepreneurial spirit, a readiness to take calculated risks and a drive to innovate. It is a dynamic workplace that fosters professional growth, with short decision-making processes and influential and visible roles. As a family-owned business, Pharmacosmos provides a supportive work environment and competitive employment terms, tailored to your qualifications and experience.

How to apply
The recruitment process is carried out in collaboration with the consulting company Compass Human Resources Group. If you want to learn more about this position before submitting your CV, please do not hesitate to contact Research Manager, Pernille Hemmingsen or Senior Director, Tom Zehngraff on telephone +45 70 20 12 75. As we process CVs continuously, we encourage you to submit your CV at your earliest convenience if you are interested. Please note that all enquiries will be handled with confidentiality and that we will reply to the email address from which you send your CV.

Apply via the blue link box in the top right.