Denisa Bruhs

Manage global regulatory projects throughout the full project lifecycle, ensuring timely delivery, quality, budget adherence, and compliance with sponsor requirements. Coordinate cross-functional teams and serve as primary point of contact for sponsors.

Supported Project Leaders in delivering global clinical research projects in compliance with sponsor expectations and regulatory requirements. Coordinated project timelines, documentation, financial tracking, resource allocation, and cross-functional communication.

Managed the editorial workflow for peer-reviewed scientific manuscripts, ensuring quality and timely publication. Planned and coordinated Special Issues by collaborating with international Guest Editors to define scientific scope and publication strategy.

Coordinated the editorial and peer-review process for scientific manuscripts. Communicated with authors, reviewers, and academic editors throughout the publication process.

Produced and purified recombinant proteins using molecular biology and protein purification techniques. Supported experimental planning, laboratory documentation, and data collection.

Performed macroscopic quality control of pharmaceutical ampoules in accordance with manufacturing quality standards.

Activities and societies: Relevant coursework: Individual Case Safety Reports (ICSRs), Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs), Pharmacovigilance System Master File (PSMF), PASS and PAES, Signal Detection and Signal Management, Benefit-Risk Assessment, Drug Safety Monitoring.

Master's degree in Pharmacovigilance with coursework in drug safety monitoring, including ICSRs, RMPs, PSURs, and signal detection.

Activities and societies: Relevant coursework: Pharmaceutical, cosmetic and food biotechnology, Fermentation, Cell culture, Bioreactors for cell culture.

Bachelor's degree in Biotechnology with coursework in pharmaceutical, cosmetic and food biotechnology, fermentation, cell culture, and bioreactors.