We are an international fast growing healthcare company and as a result of our rapid growth we are looking for:
Quality Management Officer (Pharmacovigilance / Drug Safety) (m/f)
PrimeVigilance is continuing to expand and is looking for a Pharmacovigilance Quality Management Officer to join our dynamic and rapidly expanding organization.
Based in our office in Zagreb, the Quality Officer will be responsible for ensuring that the PrimeVigilance Quality Management System is of the highest quality and in compliance with global regulations and company policies and in accordance with any Pharmacovigilance (PV) and Medical Information (MI) agreements.
- Advise, support and deliver training as per client requirements
- Production of quality and compliance metrics per client project and employee for ICSR and aggregate reports
- Oversight of corrective and preventative actions (CAPAs) for each client and management/maintenance of a centralised tracking system to ensure adequate documentation and closeout of client CAPAs
- Oversight of audits and inspections. Including pre-audit/inspection requests, audit scribing and ‘back room’ activities as required, follow-up of audit/inspection findings, maintaining CAPA log
- Managing client audits and inspections as required
- Assisting clients with PV training, as required
- Creation and maintenance of PrimeVigilance procedures and for PV and MI guidance and legislation
- Management of all controlled procedures
- Annual audit internal and external vendor audit schedule
- Management of annual PV and two yearly MI audit of the Company’s systems
- Creation and analysis of quality/compliance metrics report for monthly review at the Quality and Compliance Committee meetings
- Creation of a monthly report for the Board of Directors meeting
Qualifications and Skills:
- Qualified to degree level, ideally relating to life sciences, medical, nursing or health care or equivalent with focus on medical science or pharmacy
- Pharmaceutical industry experience of at least 2 years in Quality, Pharmacovigilance or relevant clinical development environment
- Knowledge of industry regulations and drug safety practices; with emphasis on local and international GVP, relevant GCP and GMP guidelines
- An in depth understanding of Pharmacovigilance Quality Management systems and drug safety regulatory obligations
- Experience with supporting audits
- Working knowledge of writing CAPAs
- Excellent written and verbal communication skills
- Planning and organisational skills and attention to detail
- Ability to evaluate, interpret and synthesise written information
- Self-starter, able to prioritise and plan effectively
- Work within a successful, highly – qualified and dynamic team
- Professional training and career development in a fast growing healthcare company
If you would like to be considered for this opportunity, please send your application via
application link enclosing your English CV and Cover Letter.
Unfortunately, because of the volume of applications we receive, we are not able to give status updates, but if you are invited for an interview, we will contact you directly.
Deadline for applications: 30.05.2018.