Insuvia is an outsourcing and consultancy services provider for the pharmaceutical industry. We help pharmaceutical and biotech companies make safe and effective healthcare products available worldwide by providing superior quality pharmacovigilance and regulatory affairs services.
We are looking for a Regulatory Affairs & Pharmacovigilance Specialist in Czechia. This is a fully remote position; however, residency in the Czech Republic and fluency in the Czech language are required to fulfill the responsibilities.
Main Responsibilities
Regulatory Affairs:
• Act as the local Regulatory Affairs representative; communicate with regulatory authorities regarding pre-submission strategies, regulatory pathways, compliance requirements, and submission follow-ups.
• Serve as the primary contact and subject matter expert for regulatory affairs, advising internal teams and external clients on local regulatory requirements.
• Support the preparation and submission of regulatory applications, including new marketing authorisation (MA) applications, variations, renewals, MA transfers, and related correspondence. Submit national declarations and notifications as required.
• Compile and maintain regulatory documentation and databases, track life-cycle submissions, and oversee regulatory duties for the assigned product portfolio.
• Translate and revise product information (e.g., Summary of Product Characteristics, Package Leaflet).
• Validate artworks to ensure compliance with the marketing authorisation and local legislation.
• Review promotional materials for regulatory compliance.
Pharmacovigilance:
• Act as the Local Person for Pharmacovigilance (LPPV) or Deputy LPPV.
• Conduct local literature monitoring for pharmacovigilance purposes by reviewing relevant publications selected by the literature screening vendor.
• Monitor local PV legislation and maintain awareness of regulatory intelligence.
• Support other local PV activities, including intake of ICSRs, product quality complaints (PQCs), and medical information (MI) enquiries, implementation of additional risk minimisation measures (aRRMs), preparation of PV compliance reports, and other related tasks.
Experience, Required Skills and Competencies
• University degree in medicine, pharmacy, life sciences, or a related field.
• Fluent in Czech and English, both written and spoken; knowledge of Slovak is an advantage.
• Minimum of 3 years of experience in pharmacovigilance and/or regulatory affairs.
• Strong knowledge of EU and local regulations, including SÚKL requirements.
• Ability to independently communicate with SÚKL and manage local PV/RA responsibilities.
• Experience serving as a local PV contact (LPPV or deputy) in the Czech Republic.
Why Join Us?
• Interesting, dynamic, and diverse work in a young and rapidly growing company;
• Broad opportunities for professional growth and self-expression;
• A workplace where your input is valued and makes a real impact;
• Ongoing professional training and development;
• Reasonable workload with a focus on work-life balance and flexibility;
• Fully remote position with a budget for either home-office equipment or coworking / small office space rental;
Ready to Apply?
Send your resume to [email protected]