Fred Jerva

About Fred Jerva

With over 20 years of experience in the pharmaceutical and biotechnology sectors, I have dedicated my career to ensuring the safety and efficacy of life-changing therapies. My expertise lies in leading safety surveillance for assets in clinical development and those that are marketed. I am passionate about bringing innovative treatments to patients while maintaining the highest standards of patient safety and regulatory compliance.Throughout my career, I’ve had the privilege of working on high-profile projects that have made a tangible impact on global health. From managing safety evaluations for anti-COVID antibody therapies during an unprecedented global pandemic to guiding the development of therapeutic antibodies for respiratory and inflammatory diseases, my focus has always been on delivering results that matter. My role in these projects has required a deep understanding of clinical trial design, risk management, and cross-functional collaboration—skills that I have honed over years of hands-on experience.At Johnson & Johnson, I led safety oversight for late-stage neuroscience assets, contributing to the strategic direction of safety protocols and ensuring that patient safety was never compromised. My ability to manage complex safety data and work closely with cross-functional teams allowed me to play a key role in the successful development and approval of several therapies. Similarly, at GlaxoSmithKline, I was instrumental in the accelerated development and emergency use authorization of an anti-COVID therapy, a project that required both speed and precision to meet the urgent needs of the pandemic.One of the aspects of my work that I find most rewarding is the opportunity to mentor and collaborate with others. Whether it’s guiding PharmD students through their early careers or working alongside colleagues to develop new methodologies for adverse event monitoring, I believe that teamwork and knowledge-sharing are at the core of any successful endeavor. I am committed to fostering an environment where innovation thrives, and where everyone is empowered to contribute to the collective goal of improving patient outcomes.CORE COMPETENCIES:Safety Surveillance • Risk Management • Clinical Trial Design • Regulatory Compliance • Adverse Event Monitoring • Safety Data Analysis • Pharmacovigilance • Regulatory Documentation • Biomarker Integration • Protocol Development • Clinical Endpoint Definition • Aggregate Safety Reporting • Cross-Functional Collaboration • Automated Safety Assessment • Data-Driven Decision Making

Experience

1. Associate Director, Global Safety Strategy and Risk Management

   Johnson & Johnson Innovative Medicine

   Aug 2021 — Present

   At Johnson & Johnson, I lead the implementation of surveillance strategies for proactive, systematic detection and evaluation of new safety signals and emerging trends from post-marketing safety data. My surveillance responsibilities include antibody therapies, their corresponding device delivery systems, and associated lot-based analyses. These activities include the development and use of novel computational and statistical methods for signal detection in the internal company safety database, external public safety databases, and other data sources.I\'ve led safety surveillance and risk management for late-stage neuroscience assets, ensuring patient safety across Phase II and Phase clinical trials. My role involved managing aggregate safety reporting, authoring critical safety documents, and providing strategic direction within the Neuropsychiatry Safety Advisory Group. I also served as the primary backup for the Neuroscience Therapy Area Safety Lead, where I managed cross-functional initiatives aimed at enhancing safety protocols and standards across the organization.Key Accomplishments:• Played a significant role in developing and implementing new SOPs for the review of unblinded safety data, which contributed to enhanced safety protocols.• Led efforts to harmonize adverse drug reaction (ADR) determination methods, improving consistency in safety evaluations.• Supported department-wide initiatives that leveraged translational safety data to inform early-stage program decisions, helping to enhance the strategic approach to drug safety.

Education

• University of Notre Dame

  BS, Biological Sciences

• Creighton University

  PharmD, PharmD

• Yale University

  PhD, Pharmacology

Skills

• Medical Writing
• Pharmaceutics
• Drug Discovery
• Translational Medicine
• Biochemistry
• Drug Development
• Good Clinical Practice (Gcp)
• CRO Management
• Medical Affairs
• Clinical Trials
• Lifesciences
• Biomarkers
• Protein Chemistry
• Oncology
• Infectious Diseases
• Clinical Development
• Neuroscience
• Clinical Research
• Molecular Biology
• Life Sciences
• Genomics
• Pharmaceutical Industry
• Biotechnology
• Pharmacology
• Bioinformatics
• Immunology
• Pharmacovigilance