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Who Are We ?
VIGILANCE PREMIUM SERVICES is a Tunisian company created in March 2020
We provide a full spectrum of pharmacovigilance services designed to guarantee patient safety in their use of products of the pharmaceutical industry
We provide highly qualified and experienced staff
We leverage cutting-edge technology that complies with international standards
Our Services
Treatment of Pharmacovigilance cases
Collection, evaluation, and documentation of pharmacovigilance cases
Preparation of PSURs (Periodic Safety Update Report)
Validation of summaries, assessments, and vigilance reports
Collection and use of pharmacovigilance data
Drafting, implementation, and monitoring of the application of pharmacovigilance procedures
Writing of the pharmacovigilance part of clinical study protocols, observation notebooks, and reports
Writing of the pharmacovigilance part of the AMM file and the price/transparency files
Evaluation of the "risks/benefits" of each product
Validation and implementation of risk management plans
Information and advice
Control of the application of pharmacovigilance regulations
Carrying out national and international regulatory and scientific monitoring
Awareness and training of key personnel focused on pharmacovigilance
Advice, consulting, and litigation assistance in the event of a crisis or legal action following the evaluation of pharmacovigilance information
Our Programs
Assess and monitor the risks associated with the use of a drug, cosmetic or medical device before and after marketing.
Propose measures to reduce these risks, to promote the correct use of medication, food supplements, cosmetics, or medical devices.
Guarantee patient safety.
These missions can be carried out at the local or international level.
Why Vigilance Premium Services ?
VIGILANCE PREMIUM SERVICES meets the regulatory requirements of health authorities in Tunisia and around the world.
It carries out its mission within the framework of the Tunisian Directives of Pharmacovigilance Best Practices.
Our customer base are the pharmaceutical companies wishing to subcontract pharmacovigilance activity for the drugs they manufacture and/or distribute in Tunisia and around the world.
