Pharmacovigilance & Risk Management

Regulatory clarity fromrisktoreadiness

Pharmacovigilance

& Risk Management Solutions

A reliable and effective pharmacovigilance program is more than a regulatory requirement—it is a cornerstone of patient trust and product success. With decades of experience developed as leaders in both the public and private sectors, ELIQUENT’s industry-recognized pharmacovigilance and risk management experts serve as trusted partners to global life science innovators.

ELIQUENT’s Pharmacovigilance and Risk Management Solutions are the industry gold-standard. Our expert team works across the entire product lifecycle to support innovators with precision and expertise – enabling you to confidently navigate global post-marketing surveillance, adverse event reporting, and risk management planning. No matter your pathway position, regulatory requirements, or therapeutic market – ELIQUENT’s integrated solutions align with your regulatory goals to unlock excellence.

Strategic & Technical Capabilities

ELIQUENT provides the strategic direction and technical expertise that clients count on as they encounter complex regulatory challenges. Our team of industry-recognized professionals guide clients from the earliest phases of development through post-market support. ELIQUENT’s strategic and technical Pharmacovigilance & Risk Management Capabilities include:

Operational Harmonization

Our experts drive compliant, scalable safety operations by aligning people, processes, and performance across global teams.

: Process Optimization: Streamline and redefine pharmacovigilance processes using LEAN, Six Sigma, and ISO principles.

Safety Operations: Ensure alignment with global safety standards across all operational levels.

Risk Reduction: Improve compliance through documentation, process, and team alignment.

Cost Optimization: Identify and implement strategies to reduce operational costs while maintaining quality.

Safety System Modernization

Our team delivers inspection-ready pharmacovigilance systems that streamline data, support oversight, and scale with compliance.

: ELIQUENT works with clients to optimize the following systems:

Regulatory Reporting Platforms: Ensure timely and accurate submissions across complex global requirements.

Adverse Event Reporting: Support systematic identification, analysis, and management of safety data.

Signal Detection & Risk Management Tools: Early identification of potential safety concerns.

Compliance Capabilities

ELIQUENT ensures inspection readiness and practical solutions to keep safety operations ahead of regulatory expectations.

: Regulatory Requirements: Operationalize evolving global requirements within safety systems.

Inspectional Readiness: Prepare systems, teams, and documentation for successful inspections.

Audits & Gap Assessments: Conduct proactive assessments to identify and close compliance gaps.

CAPA Close-Outs: Drive effective, sustainable resolutions through root cause analysis and action planning.

Technology Enablement

ELIQUENT modernizes pharmacovigilance systems to align with business goals and ensure scalable, compliant performance.

: Technology Audits: Assess technology options to meet business needs

Select and Implement New Technology: Guide full lifecycle from vendor selection through implementation.

Data Migrations: Manage validated, risk-mitigated transfer of safety data between systems

Safety System Upgrades: Manage enhancements and configuration updates to ensure performance.

Organizational & Talent Solutions

We build scalable pharmacovigilance teams – equipping your organization to lead in a dynamic regulatory environment.

: Staff & Project Augmentation: Provide skilled resources to support implementation and ongoing operations.

Capacity Planning & Management: Forecast and manage team needs in step with growth.

Organizational Design: Structure teams for efficiency, compliance, and adaptability.

Global PV Training: Deliver customized training programs aligned with regulatory standards.

Risk Management

ELIQUENT embeds proactive, lifecycle-wide risk management to strengthen safety strategy and ensure compliance.

: Proactive Risk Identification: Anticipate safety concerns before they become problems.

Integrated Risk Planning: Create risk strategies that are aligned, actionable, and scalable.

Effective Risk Mitigation: Translate strategy into meaningful action.

Ongoing Monitoring & Continuous Improvement: Sustain compliance and safety across the product lifecycle.

Unmatched Expertise

ELIQUENT’s team of pharmacovigilance and risk management experts collaborate seamlessly to unlock excellence across the product lifecycle. Our proven track record of success in navigating complex regulatory challenges makes us a trusted partner for companies seeking strategic guidance, streamlined approvals, and long-term compliance solutions.