Our vigilance team is comprised of physicians, pharmacists and life science professionals who provide full vigilance support for products such as generics, innovators and advanced therapies. Since 2003, we have delivered comprehensive, end-to-end high-quality pharmacovigilance services to our clients and have expanded our services into other vigilance categories such as medical device vigilance, veterinary pharmacovigilance and cosmetovigilance.
From our strategically-located European global pharmacovigilance hubs, we offer cost-effective solutions for global pre- and post-approval pharmacovigilance, as well as related services in product safety (medical device vigilance, vetvigilance, cosmetovigilance). In addition, we have highly skilled experts in multiple countries to better serve your local needs with no subcontracting.
We have implemented a specialized recruitment approach to attract the right talent for the right pharmacovigilance tasks globally and regionally.
Our strength is in our people, who possess strong academic backgrounds, deep knowledge of legislation, years of hands-on experience in pre- and post-approval projects for large and mid-size pharma, device manufacturers, etc.
Year after year, high retention rates secure continuity and are a basis for expansion. We add not only value to your system but build and sustain your image and reputation.
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of the adverse effects of using pharmaceuticals and other problems that can result from medicine use.
A combination of the Greek word pharmakon, (drug) and the Latin vigilare (to keep awake or alert/to keep watch), the objective of pharmacovigilance is to mitigate risk and monitor the use, dosage and effectiveness of drugs already on the market.
Data which sparks an investigation can surface from multiple sources, but mainly stems from new clinical trials, from unsolicited reports, or from data from post-authorization studies. This data is collected into a central Safety Database, which signals risks based on any concerning spikes or anomalies of data.
Should there be any cause for concern flagged regarding any drug or medical device, a pharmacovigilance risk assessment will be required.
The outcome of such activities include: changes in the recommended dosage for certain demographics, additional instructions for the consumer, more knowledge about side effects, or even the withdrawal of a drug from the market.
In summary, Pharmacovigilance is a practice put in place with patients’ best interest at heart, and aims to:
…covering project management in EU and non-EU, including MENA region.
GENERAL PV
VETER-INARY PV
MEDICAL DEVICE
NUTRI-TION
MISCELLA-NEOUS
COSMETO-VIGILANCE
Excelya’s Pharmacovigilance and Safety department has a dedicated, experienced and qualified team in order to provide services for assessing the performance and quality of pharmacovigilance activities. Our services include:
Post Marketing Pharmacovigilance Support
Clinical Trial Safety
Veterinary Pharmacovigilance
Medical Device Vigilance
Pharmacovigilance Auditing
Training
Cosmetovigilance
95 DEDICATED PV & SAFETY EXPERTS
95 highly trained pharmacovigilance professionals ready to go
EXTENSIVE FIELD KNOWLEDGE
Over 150 pharmacovigilance projects completed in the past 4 years
QUALIFIED TEAM MEMBERS
Highly qualified team (Master, PhD), more than 19 years experience
KNOWLEDGEABLE STAFF
Excelya seamlessly pairs specific, local knowledge with international reach
Quality has been the main focus of our pharmacovigilance and product safety services since 2003. We are proud of our client centric company culture highly sensitive to individual needs.
Excelya offer cost-effective solutions for global pre- and post-approval pharmacovigilance as well as related services in product safety (device vigilance, vetvigilance, cosmetovigilance, etc.). In addition, we have deep roots on a local level in multiple countries, enabling us to serve your local needs without subcontracting.
During the many years of our product safety operations, we have grown vigilance teams with targeted expertise to achieve operational stability. The Excelya difference comes with our lean management style, agile project implementation and short timelines, and our efficient pathways of communication.
We have new best-in-class resource management standards adapted to global capabilities and new ways of considering cycle management.
Our results speak for themselves: Excelya PV studies received exceptional internal and external results, with 100% of them flagging no critical or major findings.
With the winning combination of best-in-class knowledge and demonstrable internal processes, your PV exploits are in good hands with us.
