Profile Details

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Hire Dr. Sergio P.

Spain

USD 55 /hr

MDR Consultant / CER writer

Profile Summary

I have more than 6 years experience (research and pharmaceutical industry) with a long track of success. My years as a researcher provided me with a critical thinking, the capability to understand, analyze and summarize the results got during the experiments. 7 articles published in high impact factor journals in only 5 years showed my skills to plan, conduct experiments and get key results. Besides, I have experience in the pharmaceutical industry as medical information analyst/medical affairs . Here I got training about different therapeutic areas (Oncology, Diabetes, Osteoporosis) and the ability and expertise to perform literature research in different databases I have extensive experience writing monographs, elaborating PowerPoints, scientific studies and other scientific materials. Also, I have experience in the medical devices field, with the adapatation of CER to the new legislation, and update of the technical documentation to be alligned with the MDR Finally, I have experience in the regulatory part of the drug development, having participated in the NDA submission for the FDA and also planning the milestones for the EU submission

Subject Matter Expertise

• ☆ STEM
• ☆ Biology/Life Sciences
• ☆ Text Mining & Analytics
• ☆ Pharmaceutical Sciences
• ☆ Drug Development
• ☆ Medical Devices
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ Pharmacovigilance/Drug Safety Monitoring
• ☆ Oncology
• ☆ Diabetes
• ☆ Medical Affairs
• ☆ Osteoporosis
• ☆ Research Methodology
• ☆ Clinical Evaluation Reports (CER)
• ☆ Management Information Systems

Services

• Writing
• Research
• Consulting
• Product Development

Work Experience

Regulatory Project Planner

Pharma Mar

September 2019 - Present

Regulatory Specialist and Project Manager

Paul Hartmann

June 2018 - September 2019

Senior Manager Clinical Evaluation Premarket

Hartmann (Germany)

January 2018 - May 2018

Medical Information Analyst

Eli Lilly (Ireland)

July 2015 - December 2017

Medical Affairs

Meisys (Spain)

February 2014 - June 2015

Postdoctoral Researcher

Royal College of Surgeons in Ireland

October 2010 - February 2013

Education

Masters program about drug development

ESAME

September 2013 - June 2014

Phd

University of Castilla la Mancha, Spain

October 2007 - October 2010

Biology bachelor's degree

University of salamanca

September 2002 - June 2007

Certifications

• Certification details not provided.

Publications

JOURNAL ARTICLE

Düssmann H, Perez-Alvarez S, Anilkumar U, Papkovsky DB, Prehn JH(2017). Single-cell time-lapse imaging of intracellular O2 in response to metabolic inhibition and mitochondrial cytochrome-c release . Cell death & disease.

D'Orsi B, Kilbride SM, Chen G, Perez Alvarez S, Bonner HP, Pfeiffer S, Plesnila N, Engel T, Henshall DC, Düssmann H, et al.(2015). Bax regulates neuronal Ca2+ homeostasis . The Journal of neuroscience : the official journal of the Society for Neuroscience.

Barros-Miñones L, Martín-de-Saavedra D, Perez-Alvarez S, Orejana L, Suquía V, Goñi-Allo B, Hervias I, López MG, Jordan J, Aguirre N, et al.(2013). Inhibition of calpain-regulated p35/cdk5 plays a central role in sildenafil-induced protection against chemical hypoxia produced by malonate . Biochimica et biophysica acta.

Perez-Alvarez S, Iglesias-Guimarais V, Solesio ME, Melero-Fernandez de Mera RM, Yuste VJ, Galindo MF, Jordán J(2011). Methadone induces CAD degradation and AIF-mediated necrotic-like cell death in neuroblastoma cells . Pharmacological research.

Perez-Alvarez S, Cuenca-Lopez MD, de Mera RM, Puerta E, Karachitos A, Bednarczyk P, Kmita H, Aguirre N, Galindo MF, Jordán J(2010). Methadone induces necrotic-like cell death in SH-SY5Y cells by an impairment of mitochondrial ATP synthesis . Biochimica et biophysica acta.

Garcia-Martinez EM, Sanz-Blasco S, Karachitos A, Bandez MJ, Fernandez-Gomez FJ, Perez-Alvarez S, de Mera RM, Jordan MJ, Aguirre N, Galindo MF, et al.(2010). Mitochondria and calcium flux as targets of neuroprotection caused by minocycline in cerebellar granule cells . Biochemical pharmacology.

Perez-Alvarez S, Solesio ME, Manzanares J, Jordán J, Galindo MF(2009). Lactacystin requires reactive oxygen species and Bax redistribution to induce mitochondria-mediated cell death . British journal of pharmacology.

Valdivia A, Pérez-Alvarez S, Aroca-Aguilar JD, Ikuta I, Jordán J(2009). Superoxide dismutases: a physiopharmacological update . Journal of physiology and biochemistry.