Submit RFI/RFP SEARCH MENU PHARMACOVIGILANCE Specialist Support Outsourcing Assessment of benefit-risk The EU regulations and Guideline on Good Pharmacovigilance Practices require companies to continuously monitor the benefits and risks of their marketed medicines. This involves various activities requiring pharmacovigilance experience and expertise including: Read more Data Safety Monitoring Boards A Data Safety Monitoring Board, or Data Monitoring Committee (the terms are used interchangeably), is a committee used to monitor safety in clinical trials. They enable safety monitoring to be carried out while maintaining the blinding of the trial so that the blinding is not broken and the trial remains valid. Read more Pharmacovigilance Process Development The Good Pharmacovigilance Practice (GVP) modules and other drug safety regulations set out exacting standards for you to meet without exception and the quality documentation required for your systems and activities is extensive and specified in GVP Module I. Due to the level of complexity, most companies find they face challenges e.g.: Read more Responding to regulator safety enquiries When regulatory authorities have questions about the safety of your products or about the effectiveness of your pharmacovigilance system, you had better be able to come up with the answers. And who better to help with the response than PrimeVigilance experts and pharmacovigilance consultants who have “sat on the other side of the table”? Read more Risk Management Plan in Pharmacovigilance All applications for marketing authorisation in the EU must include a detailed and complex Risk Management Plan (RMP). In addition, renewals for older or generic products require an RMP. Read more Safety Concerns and Safety Communication Reports of issues regarding the safety of your medicinal products may come in from many different sources. Most pharmacovigilance professionals expect spontaneous reports to come in from GPs and regulatory authority but there are other sources: Read more Discover how we can help you CONTACT US Download our brochure +44 (0)1483 307920 (+1) 919-401-8003 ABOUT US Our Mission, Core Values and Vision Executive Management Team Operational Leadership Team Corporate Social Responsibility An Ergomed Group Company PHARMACOEPIDEMIOLOGY Strategic Consulting Benefit-Risk Management Services Human Data Research Services Training Systematic Literature Reviews & Meta-Analysis PHARMACOVIGILANCE Pharmacovigilance Outsourcing Support Services Outsourcing Specialist Support Outsourcing Pharmacovigilance Consulting Postmarketing Clinical trials MEDICAL INFORMATION Service Introduction Query Management Quality Management INFORMATION & RESOURCES What is Pharmacovigilance? Pharmacovigilance Information Webinars Complexities in Drug Safety Download Case Study Download PrimeVigilance brochure Download Ergomed Group brochure LOCATIONS United Kingdom (Head Office) PrimeVigilance Ltd 1 Occam Court Surrey Research Park Guildford, Surrey GU2 7HJ USA PrimeVigilance USA Inc. 100 Regency Forest Drive Suite 160 Cary NC 27518 USA Croatia PrimeVigilance Zagreb d.o.o. Oreskoviceva 20A 10020 Zagreb Germany PrimeVigilance GmbH Herriotstr. 1, 60528, Frankfurt am Main Czech Republic PrimeVigilance s.r.o. Stetkova 18 140 00 Praha 4 Serbia PrimeVigilance d.o.o. Beograd Đorđa Stanojevića 14 11070 Novi Beograd Poland PrimeVigilance – Ergomed Sp. z.o.o. Ul. Armii Krajowej 18 30-150 Krakow Japan PrimeVigilance Japan K.K. 3-1-6 Motoazabu, Minato-ku, Tokyo, Japan © PrimeVigilance 2021 An group company Sitemap Privacy policy Anti-Slavery statement Legal information