freiberufler Freelance Medical Advisor for 1) Pharmacovigilance; 2) Medical Affairs & Clinical Research; 3) Medical Writing auf freelance.de

Freelance Medical Advisor for 1) Pharmacovigilance; 2) Medical Affairs & Clinical Research; 3) Medical Writing

offline
  • auf Anfrage
  • 55270 schwabenheim
  • auf Anfrage
  • de  |  en  |  fr
  • 30.10.2018

Kurzvorstellung

Longstanding experience in preclinical and clinical drug research and drug development;
Several years of experience in Clinical Drug Safety /Pharmacovigilance;
Several years of experience in Medical Writing;

Qualifikationen

  • Marketing (allg.)
  • Medizinforschung
  • Projektmanagement
  • Technisches Projektmanagement

Projekt‐ & Berufserfahrung

(Senior) Medical Advisor/ clinical pharmacologist/ pharmacologist/ toxicologist
Boehringer Ingelheim, Behringwerke AG, Hoechst AG,, Marburg/ Ingelheim/ Frankfurt
7/1984 – offen (39 Jahre, 9 Monate)
Life Sciences
Tätigkeitszeitraum

7/1984 – offen

Tätigkeitsbeschreibung

Medical Writing/Expert Reports/ PSURs / CTD / NTA / Investigators Brochures/ Study Reports/ Summary of Product Characteristics (SmPC), CCDS (Company Core Data Sheet), CCSI (Company Core Safety Information), Patient Information Leaflet (PIL)
Several years of experience in Clinical Drug Safety/ Pharmacovigilance (3 years industry + 8 years at University)
Reader of Clinical Pharmacy, Clinical Drug Safety, Pharmacoepidemiology & Pharmacoeconomis at the Johannes-Gutenberg-University of Mainz, Member in the examining board for pharmaceutical sciences (8 years)
Longstanding experience in preclinical and clinical drug research and drug development in different pharmaceutical companies (ca. 27 years, EU, US)
therapeutical areas: coagulation, inflammation, immunology, asthma and COPD, diabetes and arteriosclerosis, nutrition, diets, phytopharmaceuticals

Type of Publication /Presentation Number
Original Articles ca. 30
Books, Book chapters and Reviews ca. 25
Abstracts/Short Presentations (Oral, Poster) > 70
Invited Lectures at Universities, Conferences ca. 30
Published Patents ca. 50


Therapeutic areas:

In Research and Development:
coagulation, inflammation, immunology, asthma and COPD, diabetes and arteriosclerosis;
by teaching and examining clinical pharmacy at the univeristy:
familiar with state-of-the-art therapeutic guidelines and drug safety in all relevant indication areas

Expertise

1. in writing and evaluation of preclinical and clinical expert reports (as needed for registration purposes) and publications
2. in writing and evaluation of clinical/medical expert reports (as needed for registration purposes) /Medical Writing
3. in pharmaceutical chemistry, analytical chemistry
4. in biopharmacy
5. in preclinical pharmacology and toxicology
6. in clinical pharmacology
7. in clinical research
8. in clinical drug safety and post-marketing surveillance /pharmacovigilance (as needed for regulatory purposes)
9. in organization, guiding and performing drug-discovery and drug development projects, including external cooperations (academic institutions, CROs); Leading drug research and drug development teams, project management
10. Involvement and experience in Due Diligence processes

Zertifikate

facharzt Klinische Pharmakologie
1995
approbation
1984

Ausbildung

medizin
staatsexamen
1984
marburg

Weitere Kenntnisse

Medizin, Pflege & Gesundheit
- Medizinische Studien / Clinical Trial

Member of the Commission for the second Phamaceutical Exam, Subject Clinical Pharmacy

Reader of Clinical Pharmacy including Clinical Drug Safety & Pharmacovigilance, Pharmacoepidemiology & Pharmacoeconomics at the Johannes-Gutenberg- University of Mainz

Board certified Clinical Pharmacologist
Board certified Pharmacologist & Toxicologist
PhD at the Philipps-University Marburg
MD at the Philipps-University Marburg
Licensed physician
Licensed pharmacist
Studies of pharmaceutical sciences, medicine and human biology at the Philipps-University Marburg



Persönliche Daten

Sprache
  • Deutsch (Muttersprache)
  • Englisch (Fließend)
  • Französisch (Gut)
  • Spanisch (Gut)
Reisebereitschaft
auf Anfrage
Arbeitserlaubnis
  • Europäische Union
  • Schweiz
Home-Office
bevorzugt
Profilaufrufe
2072
Alter
66
Berufserfahrung
39 Jahre und 8 Monate (seit 07/1984)
Projektleitung
10 Jahre

Kontaktdaten

Nur registrierte PREMIUM-Mitglieder von freelance.de können Kontaktdaten einsehen.

Jetzt Mitglied werden