Dr. med. Viola Schultze, MD, PhD
Board-Certified Specialist in General Medicine
(Germany)
Clinical Safety & Pharmacovigilance
Protecting Patients. Advancing Drug Safety
Senior Medical Consultant • Pharmacovigilance • Benefit–Risk Assessment
Expertise
From Clinical Medicine and Research to Global Drug Development and Pharmacovigilance
I am a Board-Certified Specialist in General Practice
(Germany) with more than 30 years of experience in clinical medicine, clinical research and pharmacovigilance.
I provide independent medical expertise to pharmaceutical and biotechnology companies across the entire product lifecycle, supporting Clinical Safety, Pharmacovigilance, Benefit–Risk Assessment, Signal Management and Medical Writing in accordance with Good Clinical Practice (GCP) and Good Pharmacovigilance Practices (GVP).
Areas of expertise include:
- Clinical Safety
- Benefit–Risk Assessment
- Signal Management
- Medical Writing
- Safety Evaluation
Professional Journey
More than thirty years, countless patients, more meetings than anyone should reasonably survive, a lifelong learning curve – and still curious.
Medical Education (1983–1990)
Freie Universität Berlin, Germany
Medical studies, State Examination and medical licensure (Approbation).
Clinical Medicine & Doctoral Research (1990–1997)
Hospital- and practice-based postgraduate training in Internal Medicine, combining clinical practice in Berlin with university-based clinical research at the Department of Gastroenterology, Otto von Guericke University Magdeburg.
Research focused on gastroenterology, hepatology and infectious diseases, with a particular focus on Helicobacter pylori.
Awarded the degree of Dr. med. (magna cum laude) for doctoral research on Helicobacter pylori.
This period laid the scientific and clinical foundation for my subsequent career in international clinical development and pharmacovigilance.
International Clinical Development (1997–2006)
International Clinical Lead and Core Clinical Team Member in global drug and vaccine development programmes of Chiron Vaccines.
Key development programmes
Helicobacter pylori vaccine
Hepatitis C (HCV) vaccines and therapies
Meningococcal vaccines
DTaP-IPV combination vaccine
Key responsibilities
Clinical leadership within international development teams
Clinical development strategy
Medical monitoring
Protocol development and review
Investigator support
Clinical data review
Cross-functional collaboration
Clinical Safety & Pharma-covigilance
(2006–2021)
Senior medical roles supporting international pharmaceutical and biotechnology companies (Novartis Vaccines) throughout the product lifecycle.
Areas of expertise include:
Clinical Safety
Medical Review
Benefit–Risk Assessment
Signal Management
Aggregate Reports (PSUR/PBRER/DSUR)
Risk Management Plans
Medical Writing
Independent Medical Consultant (since 2011)
Providing independent consulting services to pharmaceutical and biotechnology companies such as Boehringer Ingelheim, Meda, Merck KgA, Almirall, and Fresenius Kabi
Services included
- Clinical Safety
- Pharmacovigilance
- Medical Review
- Benefit–Risk Assessment
- Signal Management
- Medical Writing
- Pharmacovigilance training
- Training of external staff and Contract Research Organisations (CROs)
- Strategic pharmacovigilance support
2021–2026
Career break
After more than three decades in clinical medicine, clinical development and pharmacovigilance, the COVID-19 pandemic marked the beginning of an extended career break.
During this period, I devoted time to personal projects, travel and other long-standing interests.
In 2026, I returned to professional activities, offering selective consulting services in Clinical Safety and Pharmacovigilance.
2026–Present Independent Medical Consultant
Retirement was carefully considered.
However, the benefit–risk assessment favoured coming back.
Available for Selected Clinical Safety & Pharmacovigilance Projects
Today I choose projects—not because I have to, but because they are worth doing!