Rethinking Pharmacovigilance

Pharmacovigilance often appears to companies as a loosely connected network of tasks and responsibilities that run side by side without clear integration or visible added value. Start-ups tend to shy away from it due to its complexity and bureaucracy, while large corporations are hindered by rigid structures that limit agility and responsiveness to new signals or regulatory changes. As a result, valuable potential remains untapped, both in terms of efficiency and in developing pharmacovigilance as a strategic success factor. But there is another way. With a modern PV framework, pharmacovigilance can be reimagined: smart, transparent, and tailored.

Clinical Safety & Pharmacovigilance Across the Product Lifecycle: From Lab to Market

Drug safety accompanies a product from the very first idea to long after market launch (see Figure 1).
During the research and development (R&D) phase, clinical safety management is at the forefront: potential risks are assessed, studies are closely monitored, and adverse drug reactions are meticulously documented.
In the marketing authorization phase, the benefit–risk profile takes shape. Clinical data are consolidated, medically evaluated, and integrated into regulatory submissions.
After market introduction, pharmacovigilance in the true sense begins. It ensures compliance with Good Pharmacovigilance Practices (GVP) and drives the continuous optimization of the benefit–risk profile. Reports from the market, clinical data, scientific literature, and insights from real-world evidence and registry studies all contribute to ongoing benefit–risk assessment forming the foundation for safe and responsible drug use.

The Four Core Pillars of Modern Pharmacovigilance

To ensure an optimal benefit–risk profile throughout all phases of product development, clear responsibilities and interlocking structures are essential. Pharmacovigilance must not be a collection of isolated activities, but must be function as an integrated, collaborative system across disciplines.

Each stage of the product lifecycle should therefore build on four interconnected pillars (see Figure 2). Each has its own vital role, but only through their interplay does a holistic, agile, and scientifically grounded pharmacovigilance system emerge.

QPPV-Office- Coordination & Regulatory Compliance

The QPPV Office is the organizational and regulatory hub of pharmacovigilance. It oversees global coordination and governance, ensures consistent quality standards, and safeguards compliance with regulatory requirements across the company.

At its center is the Qualified Person Responsible for Pharmacovigilance (QPPV), as defined in Article 23 of Regulation (EC) No 726/2004. The QPPV is the expert responsible for maintaining and supervising an effective pharmacovigilance system. Key responsibilities include monitoring and maintaining the PV system, assessing and reporting adverse drug reactions, ensuring legal compliance, developing risk management plans, preparing safety reports (e.g., PSURs), and training staff. The QPPV acts as the primary contact for authorities and ensures that each product’s benefit–risk balance remains optimal for patients.

The team manages the Pharmacovigilance System Master File (PSMF), which is the cornerstone of the organization’s PV system. It provides a comprehensive overview of the global PV framework and its appendices, reflecting worldwide safety data for all authorized products.

Through Regulatory Intelligence, the team continuously monitors global and local guidelines to respond swiftly to change. Inspection readiness is essential in order to be able to demonstrate compliance with regulations at any time. Through continuous audits, training and process optimisation, the QPPV Office minimises risks and increases efficiency. This is based on the creation and maintenance of a user-friendly and process-oriented PV SOP system in close cooperation with QA. The QPPV Office is also responsible for PV contracts and Safety Data Exchange Agreements (SDEAs), ensuring they are legally sound and practically effective to uphold drug safety.

Center of Excellence - Strategic Analysis & Risk Management

The Centre of Excellence (CoE) serves as the intellectual core of pharmacovigilance combining scientific analysis, medical evaluation, and strategic risk management in close alignment with the QPPV.

A major function of the CoE is the preparation of key regulatory documents that ensure global compliance: Periodic Safety Update Reports (PSURs/PBRERs), Risk Management Plans (RMPs), Development Safety Update Reports (DSURs), and Additional Monitoring Commitments (ACOs). These documents support the continuous monitoring and assessment of a product’s safety profile.

At its heart, the CoE focuses on signal and risk management, two interconnected processes ensuring drug safety. Signal management identifies, assesses, and validates new potential risks, while risk management evaluates, mitigates, and implements preventive measures to ensure safe use. The ultimate goal is to guarantee that the therapeutic benefit outweighs potential risks.  

Another key responsibility is the coordination of Safety Committees, the interdisciplinary forums where safety data and signals are discussed in the context of the full product lifecycle. Here, medical and strategic decisions are shaped for the product’s future direction. The QPPV gathers input from all relevant departments but retains final authority and regulatory responsibility.

Together with the QPPV Office, the CoE drives the strategic advancement of pharmacovigilance, making it a proactive partner across all corporate functions, streamlining processes and shaping long-term PV strategies. The result: a competence center that not only ensures compliance but also fosters innovation, excellence, and medical foresight.

Operations - Case Processing & Database Management

Operations form the backbone of pharmacovigilance. This team collects, processes, and prepares safety information for further assessment.

Central to this function is case processing, both in pre- and post-marketing contexts. Cases are captured, coded (using MedDRA terminology), and medically evaluated in collaboration with the Centre of Excellence to build an up-to-date safety profile. Operations ensure timely reporting of cases to authorities in the required electronic format and oversee data management and maintenance of PV databases.

PV Community- Local Expertise & Operational Proximity

The PV Community bridges centralized oversight and local implementation. It brings together expertise from all regions, maintaining close ties with local authorities and ensuring compliance with regional requirements.

Key roles are played by Local Contact Points, who represent specific countries, such as the Stufenplanbeauftragter (SPB) in Germany. They serve as primary local contacts and report regularly to the QPPV Office. Together, they ensure that all regulatory obligations are met and PV processes run smoothly.

In Germany in particular, the SPB (defined in § 63a German medicinal product act) is responsible for maintaining a functioning PV system, meeting reporting obligations (including oversight of submitted PBRERs and RMPs), and communicating with local authorities. In daily operations, the SPB collaborates closely with Operations (which collects incoming reports) and the Centre of Excellence (which evaluates data and prepares PBRERs and RMPs).

Turning Obligation into Opportunity

For many companies, pharmacovigilance begins as a mandatory exercise, a complex, resource-heavy system that offers little visible return. Smaller firms may feel overwhelmed by its complexity, while larger ones risk being slowed by bureaucracy.

Yet pharmacovigilance is far more than a regulatory obligation. Modern PV demonstrates that it can be different: when key elements such as QPPV Office, PV Community, Operations, and Centre of Excellence work hand in hand, a connected system emerges that creates transparency, enables tailored solutions, and delivers efficiency.

What initially appears to be a loose weave of individual threads develops into the structure of a network that supports, protects and connects through collaboration and clear alignment. Those who see pharmacovigilance as an opportunity from the start create sustainable safety for patients, for the company and for the future.