Pharmacovigilance

At Pharmnova, our Pharmacovigilance (PV) services are designed to help organizations manage the safety of their products throughout their lifecycle. With a deep understanding of global regulatory requirements and a team of seasoned professionals, we deliver comprehensive PV solutions that prioritize patient safety, data integrity, and compliance.

Our Pharmacovigilance Services Include:

Adverse Event Case Management

End-to-end handling of adverse event (AE) and serious adverse event (SAE) cases, including data collection, triage, assessment, and submission to regulatory authorities.

Risk Management Plans (RMPs)

Creation, maintenance, and implementation of RMPs to identify, assess, and mitigate risks associated with your products.

Signal Detection and Management

Proactive monitoring and analysis of safety data to identify and evaluate potential safety signals and recommend appropriate actions.

Pharmacovigilance System Master File (PSMF)

Preparation and maintenance of the PSMF to ensure compliance with global regulatory requirements.

Literature Surveillance

Systematic review of scientific and medical literature to identify safety information and fulfill regulatory obligations.

Regulatory Reporting and Compliance

Timely submission of ICSRs (Individual Case Safety Reports) and compliance with local and international reporting timelines, including FDA, EMA, and WHO standards.

Medical Review

Expert evaluation of case reports and safety data by qualified medical professionals to ensure accuracy and completeness.

Pharmacovigilance Audits and Inspections

Preparation for and support during audits and inspections to ensure readiness and compliance with global PV standards.

Safety Database Management

Utilization of validated safety databases to capture, process, and store safety data securely, ensuring accuracy and traceability.

Safety Data Exchanage Agreement (SDEA)

Preparation, maintenance of SDEA with stakeholders and support ADR exchange and reconciliation as defined in agreement.

Why Choose Pharmnova for Pharmacovigilance Services?

Experienced Team

A team of highly skilled medical and PV professionals with extensive experience in global pharmacovigilance.

Expertise

Expertise in managing safety data for a wide range of products, including small molecules, biologics, and medical devices.

Customized Solution

Commitment to maintaining the highest standards of patient safety and regulatory compliance.

Established Process

Advanced technology and tools to streamline PV processes and ensure data security.

 

Ensuring Drug Safety and Regulatory Compliance!

By choosing Pharmnova, you gain a trusted partner dedicated to safeguarding the safety of your products and the health of patients worldwide.

Partner with Pharmnova to ensure compliance, safety, and trust in your pharmacovigilance operations.