Pharmacovigilance

Pharmacovigilance provides comprehensive, risk-based, flexible solutions for the management of product safety, risk and patient health during the entire lifecycle of a medicinal product.

Operational Outsourcing |  PV Consulting  | Training and Education

PAREXEL Pharmacovigilance Services is a dedicated and specialized contract safety organization offered by PAREXEL International, a leader in biopharmaceutical and medical device product development services. We offer a comprehensive portfolio of services for the active management of drug safety, risk management and patient health during the entire lifecycle of a product from preclinical through the conclusion of the marketing period of a product. Our global reach, quality systems approach, and multi-disciplinary safety expertise offers true value and quality very few companies could match on their own.

From smaller and mid-sized pharmaceutical companies looking for a tailor-made and cost effective solution to pharmaceutical companies in emerging regions requiring specific expertise to large international organizations which want to outsource drug safety functions on scale, PAREXEL has the Pharmacovigilance solution to meet their needs.

PAREXEL is the only biopharmaceutical service provider to offer Pharmacovigilance Services with the therapeutic expertise, technical credibility and cost-effective infrastructure to meet the stringent safety and compliance standards as required by international regulations. PAREXEL Pharmacovigilance is the first recognized dedicated drug safety services provider that offers the complete range of high-quality and competent drug safety services to pharmaceutical, biotechnological, and healthcare companies. The program continues across all phases of clinical development, ensuring safety, and risk management throughout clinical development and post-approval. 

PAREXEL has integrated its top experts in safety and Pharmacovigilance combined with the latest technology solutions to deliver the next generation of contract safety services to our clients today. Pharmacovigilance Services' flexible, scalable safety solutions are tailored to companies of all sizes to let them focus on their business while benefiting from the competence of a trusted provider with expert staff to meet their safety needs.

The service offering includes adverse event management, regulatory reporting, set up and maintenance of a global safety database, MedDRA coding and coding convention strategies, trend analysis and risk management and risk management strategy.  With PAREXEL’s Pharmacovigilance Services, bio/pharmaceutical companies can avoid costly setbacks that can threaten both product revenues and reputation. 

Your advantages with PAREXEL Pharmacovigilance Services:

• Access to world-leading technical expertise and operational excellence
• Significantly lower overall cost base for drug safety activities allowing re-allocation of resources
• Lower recruitment and headcount expenses
• Quality systems approach ensures compliance, leading to a reduction in business risk to due favourable inspections outcomes and  faster time to market
• Scientific developments and new regulatory requirements automatically integrated in process
• “Round-the-clock” availability and geographic reach
• Short lead-in times, clear processes and effective client management

Contact Pharmacovigilance Services.