Monika Wronka
RA Manager at Biovico- Claim this Profile
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Polish Native or bilingual proficiency
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English Professional working proficiency
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Italian Limited working proficiency
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Spanish Elementary proficiency
Topline Score
Bio
Joanna Jankowska
I had the pleasure of working with Monika in the Regulatory Affairs department in the field of medical devices for orthopedics and regenerative medicine. Monica has thorough knowledge of relevant external standards, regulations for medical devices and how to lead certification and registration projects on the EU and outside the EU market. As a manager, Monika distinguishes herself with leadership skills and effective communication. I am glad that I had the opportunity to cooperate with Monika and be part of her team.
Richard Johnson PhD
Monika is a dedicated, responsible and highly talented pharmacist whom I worked with for two years. Having people like Monika within an R&D team makes work enjoyable and rewarding. Monika has a fantastic knowledge of pharmaceutical medicines and indications utilising her experience of pharmacy to support product development. She is not only adept to considering technical issues but also able to see the bigger picture and how it affects the business as a whole. Monika was well liked by her peers and is one of the best people I have had the pleasure of managing, always listening, always challenging the status quo and ultimately producing results. I would be happy to give more details to any prospective employer if needed.
Joanna Jankowska
I had the pleasure of working with Monika in the Regulatory Affairs department in the field of medical devices for orthopedics and regenerative medicine. Monica has thorough knowledge of relevant external standards, regulations for medical devices and how to lead certification and registration projects on the EU and outside the EU market. As a manager, Monika distinguishes herself with leadership skills and effective communication. I am glad that I had the opportunity to cooperate with Monika and be part of her team.
Richard Johnson PhD
Monika is a dedicated, responsible and highly talented pharmacist whom I worked with for two years. Having people like Monika within an R&D team makes work enjoyable and rewarding. Monika has a fantastic knowledge of pharmaceutical medicines and indications utilising her experience of pharmacy to support product development. She is not only adept to considering technical issues but also able to see the bigger picture and how it affects the business as a whole. Monika was well liked by her peers and is one of the best people I have had the pleasure of managing, always listening, always challenging the status quo and ultimately producing results. I would be happy to give more details to any prospective employer if needed.
Joanna Jankowska
I had the pleasure of working with Monika in the Regulatory Affairs department in the field of medical devices for orthopedics and regenerative medicine. Monica has thorough knowledge of relevant external standards, regulations for medical devices and how to lead certification and registration projects on the EU and outside the EU market. As a manager, Monika distinguishes herself with leadership skills and effective communication. I am glad that I had the opportunity to cooperate with Monika and be part of her team.
Richard Johnson PhD
Monika is a dedicated, responsible and highly talented pharmacist whom I worked with for two years. Having people like Monika within an R&D team makes work enjoyable and rewarding. Monika has a fantastic knowledge of pharmaceutical medicines and indications utilising her experience of pharmacy to support product development. She is not only adept to considering technical issues but also able to see the bigger picture and how it affects the business as a whole. Monika was well liked by her peers and is one of the best people I have had the pleasure of managing, always listening, always challenging the status quo and ultimately producing results. I would be happy to give more details to any prospective employer if needed.
Joanna Jankowska
I had the pleasure of working with Monika in the Regulatory Affairs department in the field of medical devices for orthopedics and regenerative medicine. Monica has thorough knowledge of relevant external standards, regulations for medical devices and how to lead certification and registration projects on the EU and outside the EU market. As a manager, Monika distinguishes herself with leadership skills and effective communication. I am glad that I had the opportunity to cooperate with Monika and be part of her team.
Richard Johnson PhD
Monika is a dedicated, responsible and highly talented pharmacist whom I worked with for two years. Having people like Monika within an R&D team makes work enjoyable and rewarding. Monika has a fantastic knowledge of pharmaceutical medicines and indications utilising her experience of pharmacy to support product development. She is not only adept to considering technical issues but also able to see the bigger picture and how it affects the business as a whole. Monika was well liked by her peers and is one of the best people I have had the pleasure of managing, always listening, always challenging the status quo and ultimately producing results. I would be happy to give more details to any prospective employer if needed.
Experience
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Biovico
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Poland
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Pharmaceutical Manufacturing
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1 - 100 Employee
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RA Manager
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Mar 2021 - Present
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R&D and RA Specialist
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Jan 2020 - Mar 2021
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Arcana Institute
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Poland
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Medical Consultant in Pharmacovigilance Department
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May 2017 - Apr 2021
Monitoring of professional scientific literature in terms of therapy safety; Reporting adverse reactions and other safety issues of medicinal products for pharmaceutical companies; Familiar with GVP guidelines. Monitoring of professional scientific literature in terms of therapy safety; Reporting adverse reactions and other safety issues of medicinal products for pharmaceutical companies; Familiar with GVP guidelines.
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Super-Pharm
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Israel
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Retail
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700 & Above Employee
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Pharmacist
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Jul 2018 - Dec 2019
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Evidence Prime
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Canada
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Software Development
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1 - 100 Employee
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Junior Researcher, project
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Nov 2017 - Aug 2018
Abstracts screening phase in the development of systematic review and clinical practice guidelines. Data extraction from clinical trials. Familiar with basics of EBM and medical research methodology. Abstracts screening phase in the development of systematic review and clinical practice guidelines. Data extraction from clinical trials. Familiar with basics of EBM and medical research methodology.
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Farmina sp. z o.o.
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Poland
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Cosmetics
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1 - 100 Employee
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Regulatory Affairs Specialist
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Aug 2016 - Jun 2018
Contribution to several new product launches; Following Polish and European regulations concerning registration procedures for medicinal products; Preparation of registration dossier in CTD format; Pharmaceutical market analysis; WEU vs. generic regulatory analysis; Participation in R&D meetings at each stage of project; Coordination of Feasibility studies for new projects; Collaboration with universities, external partners, scientific institutions, Authorities to develop products; Medical devices class I - responsible for technical documentation, risk analysis and clinical assessment; Familiar with regulation on cosmetic products, cosmetic tests, PIF; Familiar with European guidelines on biological/biotechnological products, oral modified release forms, bioequivalence studies; Artworks preparation; PubMed database; IMS Health database; General support with pharmaceutical knowledge in areas of pharmacology, drug safety, clinical trials. Show less
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Pharmacist
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Nov 2014 - Mar 2016
Dispensing prescription medicines Selling OTC medicines, medical devices, dietary supplements, cosmetics Providing information about medicines, their administration and interactions Pharmaceutical care Keeping a register of controlled drugs Liaising with doctors Legal and administrative aspects of pharmacy Dispensing prescription medicines Selling OTC medicines, medical devices, dietary supplements, cosmetics Providing information about medicines, their administration and interactions Pharmaceutical care Keeping a register of controlled drugs Liaising with doctors Legal and administrative aspects of pharmacy
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Intern
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Jan 2014 - Mar 2014
Drugs dispensing Participation in ward rounds, involvement into patient drug histories Discussing treatments with other pharmacists and GPs Involvement in clinical trials Chemotherapy preparation Drugs dispensing Participation in ward rounds, involvement into patient drug histories Discussing treatments with other pharmacists and GPs Involvement in clinical trials Chemotherapy preparation
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Intern
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Oct 2013 - Dec 2013
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Universita degli Studi di Catania
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Italy
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Higher Education
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1 - 100 Employee
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Research Assistant, Department of Clinical and Molecular Biomedicine
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Mar 2013 - Jul 2013
Primary Cultures Preparation Transfection Proteins expression assays – Western Blotting Patch Clamping Formaline Test in mice Primary Cultures Preparation Transfection Proteins expression assays – Western Blotting Patch Clamping Formaline Test in mice
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Intern
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Aug 2012 - Aug 2012
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Intern
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Jul 2012 - Aug 2012
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Intern
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Jul 2011 - Aug 2011
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Education
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2016 - 2016
Clinical Trials Brillance Academy
Clinical Trials -
2013 - 2013
Universita degli Studi di Catania, Italy
Pharmacy -
2011 - 2013
Jagiellonian University
Clinical Pharmacy -
2008 - 2013
Jagiellonian University
Master's degree, Pharmacy
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