About Me
I am Dr. David Marmaros, an experienced Pharmacovigilance Physician, Medical Writer, and Safety Consultant with over 15 years of expertise in medical regulations, clinical trials, and drug safety. My career has been focused on delivering high-quality safety documentation for FDA, EMA, and global authorities, with a strong emphasis on benefit-risk evaluations, regulatory submissions, and compliance with ICH, GVP, and GCP guidelines.
Services
- Qualified Person for Pharmacovigilance (QPPV): Ensuring drug safety and regulatory compliance for pharmaceutical products.
- Medical Writing: Preparing critical documents for clinical trials and post-marketing safety, including protocols, IB, CSR, ICF, and more.
- Pharmacovigilance Services: Signal detection, risk management, benefit-risk evaluations, and audit readiness for FDA and EMA compliance.
Core Competencies
- Pharmacovigilance & Medical Safety
- Clinical Trials Documentation
- Medical Writing & Regulatory Submissions
- Signal Detection & Risk Management
- Audit Readiness & Compliance
- Project Management & Coordination
Professional Experience
With my background in both pharma and medical device industries, I have led multiple projects ensuring the highest standards of compliance with international regulations, including:
- Comprehensive safety documentation for global authorities such as FDA and EMA.
- Management of safety cases and causality assessments in large portfolios.
- Preparation of regulatory submissions, including eCTD, RMP, PSUR, labels, and more.
- Experience with clinical trials from early-phase development to post-marketing surveillance.
- Expertise in medical device safety, including MDR compliance and post-market surveillance.
Contact
For any inquiries related to safety, pharmacovigilance, or medical writing services, feel free to reach out to me:
safetyphysician@gmail.com