Who we are
We are a specialized Pharmacovigilance Consulting Firm dedicated to Medical Safety.
Our team delivers high-quality, subject matter expertise (SMEs) directly to clients, supporting all stages of medicinal product development from early to late stage as well as in the post-approval setting.
We collaborate closely with your organization to provide a Pharmacovigilance Consultant tailored to your unique needs, timelines, and priorities — whether for short-term projects or long-term engagements.
Experience
Owned and operated by Pharmacovigilance subject matter experts (SMEs), we bring firsthand knowledge of regulatory requirements and practical experience.
This expertise enables us to leverage a robust talent network, ensuring we identify skilled consultants to meet your specific project needs efficiently.
Efficiency
Our unique model eliminates the need to work with recruiters who lack direct experience in the field or an understanding of the ever-evolving regulatory landscape of Pharmacovigilance.
Effectiveness
We deliver a comprehensive strategic framework designed to support and optimize the effectiveness of Marketing Authorization Holders’ (MAH) Pharmacovigilance systems.
Services
Medical Review
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Comprehensive medical review of individual case safety reports (ICSRs)
across diverse therapeutic areas.
Aggregate Reports
Leadership or oversight in the preparation of:
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Development Safety Update Reports (DSURs)
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Periodic Adverse Drug Experience Reports (PADERs)
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Periodic Safety Update Reports (PSURs) / Periodic Benefit-Risk Evaluation Reports (PBRERs)
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Six-Month Line Listing Reports
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Additional reports, including Addendum to Clinical Overviews (ACO)
Signal Management
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Leadership or support in managing Marketing Authorization Holders’ (MAHs) internal signal detection and evaluation processes.
Health Authority Safety Inquiries
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Strategy development and leadership or support in responding to Health Authority information requests.
Study-level Expertise
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Individual contributions to study synopses, protocols, post-marketing requirements, commitments, and clinical study reports.
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Expertise in preparing Investigator Brochures, including reference safety information.
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Contributions to safety data for Investigational New Drug (IND) applications and Independent Data Monitoring Committees (IDMCs).
Risk Management Systems
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Leadership or support in creating creating initial or updates to Core Risk Management Plans (RMPs) and European Union (EU) RMPs.
Safety Sections of NDA/MAA Submissions
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Development and delivery of key submission safety messaging.
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Methodologies for identifying and selecting adverse drug reactions for Company Core Safety Information (CCSI) and other labeling documents.
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Contributions to Module 2 documents.
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