от компании (организации): ООО Ново Нордиск в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Сертификация"
с заработной платой: по договоренности
Вакансия № 20757268 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Пятница, 6 сентября 2024 года.
Дата обновления вакансии № 20757268 на сайте Работа в Москве и Московской области (МО, Подмосковье): Воскресенье, 22 сентября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 20757268 может быть уже занята. Администрация сайта Работа в Москве и Московской области (МО, Подмосковье) приносит извинения за доставленные неудобства.
Требования к опыту работы:
3–6 лет
Тип занятости:
полная занятость
График работы:
полный день
Дополнительные сведения о вакансии: Senior Pharmacovigilance Specialist
Would you enjoy helping to move the pharmaceutical industry forward by facilitating pharmacovigilance activities? Do you want to join a team of experts who are passionate doing his job and work in the international and intercultural environment? If yes, join us on an exciting journey where we will establish our presence in different therapeutically areas and build a diverse pipeline.
We are a global healthcare company, founded in 1923 and headquartered just outside Copenhagen, Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity, and rare blood and rare endocrine diseases. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure the diseases we treat. We employ more than 45,000 people in 80 offices around the world, and market our products in 169 countries.
The position
As the Senior pharmacovigilance specialist you will be responsible for EAEU countries (Russia, Belarus, Kazakhstan, Kyrgyzstan, Armenia), where you will establish and maintain Pharmacovigilance system in accordance with EAEU regulations in the EAEU countries. Your responsibilities will include development, planning, keeping up to date and storing the Master File of the pharmacovigilance system (EAEU PSMF) in accordance with the EAEU requirements. You will be also a person, who ensures monitoring of PV regulation in EAEU countries and implementation of appropriate changes in existing processes and compliance to any update.
Position’s key accountabilities with regards to Russia & Belarus include:
- Assessment of pharmacovigilance system of external partners, responsible for contacting customers and handling safety information during Customer Engagement Programs (patient support programs (PSP), market research programs (MRP)).
- Preparation and approval of Safety Data Exchange Agreements (SDEA) with external partners, in close collaboration with HQ, if applicable.
- Approval of materials for research programs in social media and digital communication channels, development of Internet resource sponsored by NN.
- Ensure that procedures are in place to assure the required reports are sent to the regulatory authorities within regulatory timelines and that relevant monitoring mechanisms are in place.
- Maintaining of corporate system (HALO PV) with legislation requirements.
- Assessment, preparation and approval of local Risk Management Plan (RMP), if applicable, and responsible for tracking and implementing risk minimization measures provided by the RMP.
- Support the audit/inspection preparation, including ensuring affiliate’s readiness for PV audits and inspections.
- Keeping updated with relevant NN SOPs and ensure compliance.
- Check of safety mailbox on every business day basis with further timely handling of all incoming issues.
- Supervising the handling of safety information in clinical trials in Russia.
Qualifications
We expect you have a University Degree in Medicine, Pharmacy, nature science or any relevant education and 4 years of experience in pharmaceutical industry (pharmacovigilance). You have an expert knowledge of pharmacovigilance principles and regulatory requirements in EAEU countries.
You are an active team-player, have excellent cooperation skills, and are used to work with people who have very diverse professional and/or cultural background. You have independent learning skills and attention to details.
You are fluent in Russian and English (both verbal and written).
About the department
You will join our Regulatory Affairs department, which belongs to Clinical Medical and Regulatory family, based in Moscow, Russia. This position will report to the Head of Regulatory Affairs and Pharmacovigilance.
Working at Novo Nordisk
At Novo Nordisk we recognise that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and the communities we operate in.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We are happy to discuss flexible working, depending on the role and subject to business needs.
Откликнуться на эту вакансию: Senior Pharmacovigilance Specialist
Предыдущая вакансия:
Вакансия № 20757262 на должность Ассистент отдела регистрации лекарственных средств от компании ООО Альпен Фарма в городе (населенном пункте) Москва