Keith A. Fowler
Director | Safety Scientist Lead | Global Drug Safety & Pharmacovigilance | Expertise in Signal Detection, Clinical Safety, Aggregate Reports Prep, Benefit-Risk Assessment | Mentor |
- Role
- Director, Safety Scientist Lead, Global Drug Safety & Pharmacovigilance at Genmab
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
About Keith A. Fowler
Experienced leader in the pharmaceutical industry possessing comprehensive knowledge and experience in pharmacovigilance, clinical safety, benefit-risk assessment, regulatory compliance, signal detection and signal management. Demonstrated success in leading and managing a team of safety scientists to execute pharmacovigilance activities and strategies for global drug development across the product-life cycle. Extensive experience in evaluating with the evaluation and interpretating adverse event data from clinical trial and post-market sources. Strong working knowledge of ICH, GCP ad GLP guidelines in support of product-life cycle development and regulatory submissions. Proven ability to drive safety surveillance, signal detection activities, preparation of aggregate reports, support to development of strategies for risk management/ process improvement, inspection readiness and literature reviews. Highly collaborative with a strong ability to connect and engage with colleagues including senior stakeholders. Proactive partner and contributor to creating and implementing initiatives and projects, fostering innovation, growth, and continuous improvement.
Experience
Director, Safety Scientist Lead, Global Drug Safety & Pharmacovigilance
Sep 2025 — Present
Education
Hibernia College
Masters of Science, Pharmaceutical Medicine
Emory University School of Medicine
Residency, Laboratory Animal Medicine and Pathology Residency
Tuskegee University
Doctor of Veterinary Medicine, Veterinary Medicine
Rutgers University
Bachelor of Science - BS, Pharmacy
Tuskegee University
Doctor's Degree
Skills
- Regulatory Submissions
- Medical Writing
- Pharmaceutics
- Drug Discovery
- Quality Assurance
- Clinical Trials
- Ich-Gcp
- Infectious Diseases
- Pre-Clinical Studies
- Diabetes
- Ind
- Biotechnology
- Clinical Research
- Pharmacovigilance
- Drug Development
- Neurology
- Clinical Development
- Gcp
- Biopharmaceuticals
- Oncology
- Regulatory Affairs
- CRO
- Pharmacology
- Pharmaceutical Industry
- Fda
- Drug Safety
- Glp
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