12/11/2024 updated

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Experienced Medical Writer and Pharmacovigilance Expert

Praha 10, Czech Republic
Worldwide
PhD in Biomedicine
Praha 10, Czech Republic
Worldwide
PhD in Biomedicine

Profile attachments

CV_Lapka_Marek_112024.docx

Data AnalysisClinical ResearchRegulatory ComplianceData VisualizationPharmacovigilanceJournalsProject ManagementMedical WritingRegulatory RequirementsScientific LiteraturesDetection TheoriesClinical Trial ProtocolsLiteratureRegulatory AffairsSafety Principles
Medical Writing
Extensive experience in medical writing for various pharmaceutical documents, including regulatory documents, clinical trial protocols, and educational materials.

Pharmacovigilance
Expert in pharmacovigilance activities, including literature screening, signal detection, and safety evaluations for pharmaceutical products.

Clinical Research
Strong background in clinical research, including experience as a clinical studies coordinator and knowledge of various therapeutic areas.

Regulatory Affairs
Knowledge of regulatory requirements and experience in preparing documentation for regulatory authorities.

Data Analysis
Proficiency in data analytics and visualization tools, including SigmaStat and Sigmaplot.

Scientific Publishing
Author of multiple peer-reviewed publications in reputable scientific journals.

Project Management
Experience in managing and coordinating various pharmaceutical projects and clinical trials.
 

Languages

GermanBasic knowledgeEnglishFluentFrenchBasic knowledge

Project history

Medical Writer

Excelya
Dedicated to Sanofi projects

PV specialist and medical support

Tepsivo s.r.o.
Literature screening, signal detection, elaboration of PSURs/DSURs/PADERs

Senior Medical Writer

Pharmexon, s.r.o.
Elaboration of Regulatory documents, Briefing Books, eCTD modules, SOP and WI elaboration, Signal Detection Report compilation

Local Responsible Person for Pharmacovigilance and Local Person for Literature Screen

Baupharma, s.r.o.
Communication, check of authority website, literature screening for clients Baxter, Clinuvel, Eignapharma

Independent Pharmacovigilance auditor/consultant and Medical Writer

Various
For CRO clients and Pharmacovigilance consultant companies (SDEA revisions, auditor activities, literature screening, elaboration of documents etc.)

Medical Writer

Oxygen Biotech
Elaboration of trial protocols, Final reports, Brochures, research, planning and execution of the Development plan, preparation of dossier, marketing, and educational materials

Medical Writer

GCP-Service, s.r.o.
Elaboration of trial protocols, Final reports, Brochures, research, planning and execution of the Development plan, preparation of dossier, marketing, and educational materials

Independent Author and Contributor

Various local Expert Journals
Contributing to several local expert journals

Publishing

Edukafarm, PharmaNews, Premediapharm and Axonia
Collaboration and preparation of dossier materials, documentation for several projects including Development phase

Consultant and Medical Writer

Collective Connections, Edukafarm, Premediapharm and others
Preparation of publication and educational materials

Regular lecture activities

PGS
General and Clinical pharmacology, Neurosciences for courses General medicine, Nurse, Physiotherapy

Active scientific work, publishing

Various
Active scientific work and publishing

Copywriter and consultant

Salvia Paradise Company
Copywriter and consultant for Salvia Paradise Company

Expert lectures and Medical Writer

Various Pharmaceutical companies in Czech Republic and Slovakia
Participation in local documentation, preparing educational materials, communication with the Regulatory authorities and expert chambers

Health supervision and Head chief

Summer camps for children
Health supervision and Head chief on the summer camps for children

Independent consultant in healthcare system

Deloitte Advisory s.r.o.
Risk Advisory Department

Senior Drug Safety Expert

Zentiva
Pharmacovigilance Department, elaboration and review of trial protocols, Final reports, Brochures, PBRERs, ACOs, RMPs, DSURs, safety evaluations, communication with authorities

Drug Safety Expert

Zentiva
Pharmacovigilance Department

Active pharmaceutical practise

Tilia Pharmacy
Prague 10, IPC Pharmacies

Global Safety Officer

Zentiva
Pharmacovigilance Department

Clinical studies coordinator, Pharmacist, local Clinical research associate and Quality Management

Various
Experience in Clinical Trials phase II and III– Osteoporosis, Rheumatoid arthritis, Psoriasis, Hypercholesterolemia, Osteoarthritis; CCR Prague (review of protocols, ICFs, CRFs, IBs, safety reports, SUSARs LL etc. from the perspective of the Investigator)

Professional lectures and Medical Writer

Edukafarm, Premediapharm and Pharmanews companies
Organized for Edukafarm, Premediapharm and Pharmanews companies

Pharmacy practise in Magistra Pharmacy

Poliklinika Modřany
Pharmacy practice in Prague

Lifeguard

Swimming pool Flošna in Hradec Králové
Lifeguard at the swimming pool Flošna in Hradec Králové

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