At Billev Pharma East Ltd., we appreciate motivated individuals who are interested in becoming part of our team. Even if we do not currently have an open position that fits your profile, you are welcome to send us your CV and a short motivation message to our official email address: office@billeveast.com. We will be happy to get in touch when a suitable opportunity arises.
(m/f)
We are looking for a Qualified Person Responsible for Pharmacovigilance (QPPV) to ensure the establishment, maintenance and oversight of a compliant pharmacovigilance system, in line with EU and national regulatory requirements. This is a key role with a significant impact on patient safety and regulatory compliance.
Establishing, maintaining and overseeing the pharmacovigilance system
Ensuring continuous oversight of product safety profiles, signal detection and risk management activities
Preparing, reviewing and submitting PSURs, ICSR/SUSAR reports and other safety documentation
Creating, maintaining and updating the Pharmacovigilance System Master File (PSMF)
Acting as the primary contact with regulatory authorities and ensuring timely and complete responses to requests
Supporting regulatory activities and post-authorisation clinical trials
Planning and delivering pharmacovigilance training
Leading and participating in complex expert and project teams
Acting as the primary contact for pharmacovigilance inspections
University degree or Master’s degree in Pharmacy, Medicine or Veterinary Medicine
Minimum 2 years of experience in pharmacovigilance
Solid knowledge of pharmacovigilance processes and regulatory requirements
Fluency in English; working knowledge of Slovenian
High level of responsibility, independence and attention to detail
Willingness to ensure 24/7 availability, as required for the QPPV role
Residency in an EU Member State
A key expert role with high regulatory and safety responsibility
A professional, regulated and internationally oriented working environment
Participation in complex and high-impact projects
Opportunities for continuous professional development
If you are motivated by a high-responsibility role in pharmacovigilance and wish to contribute to medicine safety, we invite you to submit your application with a CV.
(m/f)
We are seeking an experienced Head of Regulatory Affairs to lead and further develop our Regulatory Affairs function. The role is responsible for ensuring regulatory compliance, defining regulatory strategies, and leading a team that supports the successful registration and lifecycle management of products in accordance with EU and national legislation.
Leading, planning, organising and overseeing the Regulatory Affairs department
Preparing the annual work programme and budget for the department and contributing to the company’s overall business and financial planning
Monitoring performance indicators and reporting on goal achievement, with proposals for continuous improvement
Ensuring compliance with applicable laws, guidelines, standards and internal policies
Developing and implementing regulatory strategies across product lifecycles
Preparing, reviewing and approving regulatory and registration documentation, including product information
Coordinating and submitting regulatory applications and variations
Maintaining registration dossiers and regulatory documentation (CTD, eCTD, VNeeS)
Acting as the primary contact and maintaining effective communication with regulatory authorities
Monitoring regulatory trends and maintaining regulatory intelligence
Supporting the establishment and maintenance of the quality management system
Delivering and coordinating regulatory training
Leading and participating in complex expert and project teams
University degree or Master’s degree in Biology, Pharmacy, Chemistry, Medicine or another relevant life science discipline
Minimum 5 years of experience in Regulatory Affairs, including at least 2 years in a leadership role
Strong knowledge of medicinal product registration legislation
Additional knowledge of regulations related to medical devices, food supplements, cosmetics or biocides is an advantage
Fluency in English; working knowledge of Slovenian
Proven leadership, organisational and communication skills
Strategic mindset with strong analytical and problem-solving abilities
A senior leadership role with significant strategic impact
A dynamic, regulated and internationally oriented environment
Participation in high-level and complex regulatory projects
Opportunities for continuous professional development
If you are an experienced regulatory professional ready to take on a leadership role, we invite you to submit your application with a CV.
Billev farmacija vzhod, d. o. o.
Billev Pharma East Ltd.
Tržaška cesta 202
1000 Ljubljana
Slovenia
Join a team of passionate professionals redefining the pharmaceutical industry. At Billev Pharma East, we foster a collaborative environment where innovation thrives, and every member is valued. Together, we make a positive impact on healthcare.
Regulatory Affairs
Pharmacovigilance
Medical Consultancy
Medical Affairs
Quality/GxP
Digital Consultancy
Medical Devices and In Vitro Diagnostics
