PrimeVigilance, an Ergomed Group company, was established in 2008 by Dr. Miroslav Reljanovic together with co-founder Dr. Elliot Brown. PrimeVigilance offers holistic, top quality, cost-effective, innovative safety services for pharmaceutical, generic and biotechnology companies. Our founders and leaders have an unrivalled reputation in the sector with a network of expert associates across the world.

• Performing quality control of weekly/monthly regulatory intelligence screenings of global Regulatory Agencies websites, with focus on pharmacovigilance and medical device vigilance
• Maintaining pharmacovigilance regulatory reporting requirements and performing quality control of updates to regulatory requirements tables
• Maintaining up-to-date knowledge of regional and national pharmacovigilance regulations, guidelines and advisory documents for post-marketing, clinical trials and medical device reporting
• Providing pharmacovigilance regulatory intelligence advice to Company employees and the clients
• Participating in preparation for audits/inspections and providing department representation

• Proficiency in English, both written and verbal
• Previous experience within the pharmaceutical/CRO industry
• Degree in Chemistry or Life Sciences, Nursing, or equivalent experience
• Good planning and organizational skills
• Good written and verbal communication skills to clearly and concisely present information
• Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
• Good attention to detail
• Excellent self-motivation skills
• Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint

What we offer

• Diverse tasks - data mining, screenings, analysis, requirements review.
• Chance to build a broad and comprehensive knowledge on PhV processes and requirements
• Chance to expand knowledge on other areas covered by Regulatory and Clinical Delivery department i.e. clinical trials, marketing authorisations, XEVMPD, PV Network
• A role in development of RI processes in a motivating environment