Artem Chumak Email & Phone Number

A seasoned Pharmacologist with over a 10 years in the Pharma industry, specialized on Regulatory affairs, Pharmacovigilance, Clinical trials, Labeling and Quality control, issues and assurance. Possesses extensive experience working with manufacturer authorization holders and manufacturing sites of human pharmaceuticals, also with veterinary pharmaceuticals, food supplies and medical devices. Experienced in conducting internal and external audits, managing workflows, crisis management, corrective and preventive actions, creating and updating standard operating procedures and training programs, under revolutions, war and plenty of major updates of legislation and Authority system.Expert in developing and maintaining pharmacovigilance systems and master files, development of registration dossier for medical products and conduction of registration, re-registration, and variation procedures. Adept at working as staff and as a sole proprietor outsource for companies across the CIS, EU, UK and USA. Skilled in effective communication with government authorities, ensuring compliance according EMA and FDA guidelines, Good Practices requirements, ISO and local legislation. Keeping strong self and team management capabilities, consistently maintaining of compliance adherence and operational excellence.

Listed skills include Продажи Фармацевтической Продукции, Доступ На Рынки, Нормативно Правовое Обеспечение, Заявки На Регистрацию, and 2 others.