Pharmacovigilance and safety expertise from first-in-human clinical trials through post-market surveillance.
Vigilance
KEY FIGURES
60%
Projects related to rare disease and gene therapy
10+
Therapeutic areas
>98%
Case quality score for 2023/2024
SOLUTIONS
- Safety database set-up and maintenance
- Case processing from intake through regulatory submission
- Case exchange with partners and affiliates
- Regulatory intelligence
- ICSR and Aggregate report submission to health authorities
- Communication with Health Authorities
- Health authority communication and electronic portal management
- Risk Management Plan (RMP) development
- Signal identification, investigation and validation per FDA guidance, EMA GVP Module IX and CIOMS VIII
- Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs) and Development Safety Update Reports (DSURs)
- Risk Management Plans (RMPs)
- Pharmacovigilance System Master File (PSMF) preparation
- QPPV and LPPV appointment
- EudraVigilance registration
Why partner with VCLS?
Global, in-house safety experts
A global vigilance team works around the clock, combining qualified safety professionals with dedicated project management to keep your pharmacovigilance running reliably at any scale.
Our safety scientists identify, investigate and validate signals against current FDA, EMA and CIOMS standards, turning safety data into clear, defensible decisions.
Patient safety at the center
Vigilance begins and ends with patient safety. Our quality and vigilance systems keep the patient at the center of every outcome while meeting stringent global regulatory requirements.
Biotech in France
Head of Clinical
FAQs
How are vigilance responsibilities managed in the US?
Like in the EU, in pre- and post-market vigilance in the US, it is the sponsor (and Marketing Authorization Holder – MAH) who takes ultimate responsibility for vigilance processes and outcomes.
However, unlike the EU, there is no requirement for a qualified person for pharmacovigilance, nor any local representatives.
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Do I have to have a Global Safety Database for a product?
There is no obligation to have one single global safety database, however it is highly recommended.
If you have multiple studies/marketing authorizations in multiple countries, to enable easy aggregated analysis of all safety data for one product.
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Related Glossary
Questions? Get the answers by our expert team
No two product developments are the same, talk to our experts about your development challenges and we will provide your actional recommendations.