Pharmacovigilance Consulting Services
Pharmacovigilance (PV) regulatory requirements are constantly evolving. At the same time, the volume and complexity of collected safety data continue to increase, coming from an expanding variety of sources and shifting rapidly.
The experienced team of PV professionals at Med Communications can provide companies in the biomedical industry with the support they need for navigating this complex and dynamic environment, ensuring full compliance with regulations across all markets and streamlining the process of managing safety data. Our knowledge spans across various therapeutic areas and geographical regions and all phases of product development.
Building on years of hands-on experience and leveraging a well-established quality management system, PV processes, and appropriate digital tools, our PV professionals can help companies establish a fit-for-purpose PV system, on time and on budget.
We can work with you to optimize your PV system and processes by helping you:
- prepare standard operating procedures (SOPs), working instructions and handling guides, templates, trackers, job descriptions, training plans, and aggregate reports
- perform literature screening and full safety signal evaluation and documentation, in compliance with applicable guidelines
- prepare responses to requests coming from regulatory authorities
- perform medical review of safety data.
We can also provide guidance and support during audits and regulatory inspections, write and implement safety data exchange agreements with corporate partners, offer drug safety database support, and assist with vendor selection. Our project leaders, dedicated senior PV professionals, handle your PV project end to end and serve as your point of contact, applying excellent communication and project management skills.
Working with our team of PV professionals can help elevate your business by improving safety and compliance standards and streamlining PV processes. This, in turn, can help you save time and money by allowing your in-house experts to adopt a more strategic role to improve the safety profile of your products.