Karel Tejkal
Pharmacovigilance & Regulatory Affairs Manager
Prague
Summary
Senior Pharmacovigilance and Regulatory Affairs professional with a track record in designing and implementing PV systems for orphan and innovative products. Experienced in managing GVP and GxP compliance across EU and global markets, including audit conduct, risk management planning, and local PV network coordination. Skilled at leading cross-functional teams and ensuring long-term compliance with a consistent focus on patient safety.
Overview
11
11
years of professional experience
2
2
years of post-secondary education
3
3
Languages
Work History
Regulatory Affairs and Pharmacovigilance Manager
ExCEEd Orphan s.r.o.
01.2023 - Current
- Designed, created, and implemented a full pharmacovigilance system for an orphan/innovator product portfolio, including quality documentation, training, audit plans, and CAPA oversight.
- Led the tender, implementation, and GAMP validation of a Document Management System for PV operations.
- Acted as the sole PV and RA compliance lead, including communication with MAH senior leadership and NCA assessors, and was responsible for multiple EU and MAH-led audits, receiving consistent, positive compliance feedback.
- Created a regional LSO network and ensured the fulfillment of local and EU GVP obligations across multiple territories.
Head of Dossier Management
PRO.MED.CS
01.2021 - 01.2023
- Managed a team of regulatory specialists responsible for full global regulatory lifecycle oversight of multiple MAHs.
- Responsible for validation and use of GxP-compliant IT systems in a system ownership role.
- Established SOPs and workflows for third-party regulatory partner oversight.
- Developed and negotiated unified contract templates for regulatory vendors, improving legal consistency and cross-functional clarity.
Regulatory Strategy & Zone Manager
PRO.MED.CS
01.2020 - 01.2021
- Directed a regulatory team responsible for expansion planning for markets outside the EEA (LATAM, GCC, AUS).
- Managed cross-functional strategy initiatives to execute regional submissions in line with local regulatory frameworks.
Senior Regulatory and Scientific Specialist, Project Manager
PrimeVigilance Ltd.
01.2018 - 01.2019
- Authored RMPs, PSURs, PBRERs, and performed benefit/risk assessments for authorized medicinal products.
- Acted as Local Safety Officer (Czechia and Slovakia), and was responsible for literature screening in France and Luxembourg.
- Managed 60+ contractors across the EEA for pharmacovigilance and regulatory affairs projects.
- Provided strategic consultancy and oversight for client PV and regulatory operations.
Marketing Authorization Coordinator, PV Liaison
State Institute for Drug Control
01.2015 - 01.2018
- Managed marketing authorization applications and post-authorization variations for EU and national procedures.
- Reviewed product information, promotional materials, and artworks for compliance.
- Defined and catalogued legal obligations related to product safety, including aRMMs, PASS and other post-authorization measures.
- Supported CMDh/CHMP topics and led internal assessment report coordination for CZ RMS procedures.
Education
Master's degree - Genetics, Molecular Biology And Virology
Charles University
Prague 01.2013 - 01.2015
Skills
Pharmacovigilance system oversight
GxP Compliance
Risk Management Planning
Pharmacovigilance auditing and inspection readiness
CAPA management
Product information and Labelling
Cross-functional teams leadership
Quality Assurance
Medical Writing
Regulatory lifecycle management (EU and Global)
Timeline
Regulatory Affairs and Pharmacovigilance Manager
ExCEEd Orphan s.r.o.
01.2023 - Current
Head of Dossier Management
PRO.MED.CS
01.2021 - 01.2023
Regulatory Strategy & Zone Manager
PRO.MED.CS
01.2020 - 01.2021
Senior Regulatory and Scientific Specialist, Project Manager
PrimeVigilance Ltd.
01.2018 - 01.2019
Marketing Authorization Coordinator, PV Liaison
State Institute for Drug Control
01.2015 - 01.2018
Master's degree - Genetics, Molecular Biology And Virology
Charles University
01.2013 - 01.2015
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