Perspective Pharmacovigilance
Perspective Pharmacovigilance is a leading provider of pharmacovigilance services, specializing in drug safety operations, safety sciences, risk management, and compliance monitoring for pharmaceutical and biotechnology companies worldwide. With a highly skilled team and over 19 years of experience, they collaborate with clients globally to deliver innovative, tailored solutions that ensure compliance, patient safety, and efficient drug development and post-market activities.
Industries
Nr. of Employees
small (1-50)
Perspective Pharmacovigilance
1280 Boulevard Way, Suite 215, Walnut Creek, CA 94595
Services
Facilitate PV program strategy, gap assessment, and a phased roadmap to build scalable pharmacovigilance capabilities.
Provision of outsourced PV operations including ICSR intake, case processing, narrative writing, expedited reporting, and SAE reconciliation.
Authoring and coordination of aggregate safety reports, development of risk management plans, and implementation of safety surveillance strategies.
Selection and configuration of safety databases, data migration between systems, and computer system validation to meet regulatory expectations.
Develop and maintain PV quality management systems, perform inspection readiness activities, and support regulatory inspections and audits.
Facilitate PV program strategy, gap assessment, and a phased roadmap to build scalable pharmacovigilance capabilities.
Provision of outsourced PV operations including ICSR intake, case processing, narrative writing, expedited reporting, and SAE reconciliation.
Authoring and coordination of aggregate safety reports, development of risk management plans, and implementation of safety surveillance strategies.
Selection and configuration of safety databases, data migration between systems, and computer system validation to meet regulatory expectations.
Develop and maintain PV quality management systems, perform inspection readiness activities, and support regulatory inspections and audits.
Expertise Areas
- Pharmacovigilance and drug safety operations
- PV strategy and organizational build-out
- Signal detection and safety analytics
- Regulatory compliance and safety submissions
Key Technologies
- Safety case management systems and ICSR databases
- Electronic data capture and clinical safety databases (EDC/clinical DBs)
- Adverse event coding and standardized medical terminologies
- Signal detection and quantitative safety analytics