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

7/1984 – offen

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