Why Governance, Continuity, and Trust Matter More Than Ever in Pharmacovigilance
Pharmacovigilance outsourcing solves capacity challenges, but it doesn’t replace the regulatory accountability sponsors hold for governance and decision-making. This article explores why meaningful partnerships, long-term senior safety involvement, and strong governance design are essential in a modern PV system, and why biopharma teams choose Perspective Pharmacovigilance for support.
Strategic Pharmacovigilance: Building Scalable, Trusted Systems from Development to Commercialization
Pharmacovigilance is evolving beyond compliance. For growing biopharma organizations, success depends on scalable safety systems, transparent partnerships, and proactive risk management that keep pace with innovation. This article explores how Perspective Pharmacovigilance helps companies align scientific excellence with operational flexibility to support safe, confident growth.
Perspectives Webinar Series — Webinar 2: Structured Benefit-Risk and Achieving Operational Success
Episode 2 of the Perspectives Webinar Series explores how structured benefit-risk can drive clearer planning, stronger governance, and more confident decision-making for small and mid-sized biopharma teams. This session highlights how appropriate structure creates measurable operational value without unnecessary complexity.
From Development to Market: Building a Pharmacovigilance Roadmap that Scales with Your Program
Transitioning from clinical development to commercial launch is one of the most critical and complex phases for any biotech company. This article explores how strategic pharmacovigilance planning, from early-stage design to post-marketing oversight, helps ensure a seamless and compliant transition across global markets.
Expanding Our Expertise with Former FDA Leadership: Strengthening Risk Management and Regulatory Strategy for Biopharma
Perspective Pharmacovigilance has expanded its leadership network with experts who bring decades of regulatory and pharmacovigilance experience from the U.S. Food and Drug Administration. This addition strengthens our ability to help biopharma innovators design smarter risk management strategies, build inspection-ready systems, and navigate regulatory expectations with confidence.
EU Pharmacovigilance Regulation 2025/1466: What Biotech Companies Must Do Now to Prepare for 2026
The EU’s new pharmacovigilance regulation introduces major changes for biotech and pharma companies operating in Europe. Learn what’s behind Regulation 2025/1466, what it means for safety governance, and how to prepare for full compliance by February 2026.
Perspectives Webinar Series — Webinar 1: Structured Benefit-Risk: From Framework to Function
Why structured benefit-risk is more than a regulatory expectation. This webinar introduces PPV’s pragmatic, hybrid approach for biotech innovators, designed to improve decision-making, align with regulators, and adapt across the product lifecycle.
Perspective Pharmacovigilance and RegDev Announce Strategic Partnership
Perspective Pharmacovigilance, Inc. and RegDev, Inc. Announce Strategic Partnership to Provide Best-in-Class Molecule to Market Services
Kieran O'Donnell Joins Perspective Pharmacovigilance as EU Practice Lead
Perspective Pharmacovigilance Strengthens EU Leadership Team with Appointment of Kieran O'Donnell as Managing Director and EU Practice Lead