Services in Focus: Pharmacovigilance
Med Communications delivers end-to-end pharmacovigilance services built for today’s global, technology-driven safety landscape. Our capabilities span the full lifecycle of PV operations:
- Global Case Processing (clinical and post-marketing, all E2B standards)
- Aggregate Safety Reports (DSUR, PBRER/PSUR, RMP annexes)
- Signal Detection and Safety Surveillance
- PV Strategy and Consulting
- Pharmacovigilance System Master File (PSMF) and Audit/Inspection Readiness
- Clinical Trial Safety Management
- Global Literature Surveillance (automated and manual workflows)
- Risk Management Planning and Implementation
Our team of highly skilled pharmacovigilance professionals is led by global pharmacovigilance director Maria Anitan, MD. These professionals bring practical experience and diverse perspectives to the table, having worked with a variety of product portfolios including pharma, vaccine, cosmetics, medical devices, and combination products. Our PV specialists have medical, pharmaceutical, and scientific backgrounds, and many held positions in sponsor and MAH organizations before joining Med Communications. They are independent thinkers who help create tailored solutions for our clients and adapt to evolving needs of the industry. Backed by the latest applicable technology, our staff is able to provide flexible and compliant solutions for our clients, acting as true partners for your in-house teams.
Med Communications works closely with clients to cover all aspects of the pharmacovigilance process, including individual case safety reports, periodic reports, signal detection activities, and reports to regulatory authorities. We have established pharmacovigilance systems in the US and many countries worldwide, including in the EMEA and APAC regions.
We continuously keep track of technological trends and the regulators’ views on them, as we are exploring possibilities to leverage technology in order to optimize our internal PV processes and increase efficiency while decreasing costs.
Contact us today to discuss how we can support your pharmacovigilance needs: 877-477-0977 or https://medcommunications.com/contact-us/.