от компании (организации): Kelly Services в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Клинические исследования"
с заработной платой: по договоренности
Вакансия № 5025546 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Понедельник, 9 сентября 2024 года.
Дата обновления вакансии № 5025546 на сайте Работа в Москве и Московской области (МО, Подмосковье): Воскресенье, 29 сентября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 5025546 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: Local Pharmacovigilance Manager
Job Responsibilities:
- Responsible for local Pharmacovigilance System (EMR)
- To ensure all local affiliate responsibilities are fulfilled as documented globally and in the PSMF
- Intake, if applicable translate, and forward Adverse Events regarding pharmaceuticals and medical devices for processing within the Global Pharmacovigilance and Risk Management (GPRM) team, ensuring all cases are processed in a timely manner
- Perform/manage reconciliation of Adverse Events for EMR
- Prepare and manage local SOPs and written procedures according to local legislations and in line with Pharmacovigilance global SOPs
- Ensure that local pharmacovigilance system is managed with local SOPs
- Preparation and updating of SDEAs
- Acting as the local Pharmacovigilance (PV) contact person for local health authorities and for the EU QPPV, as required
- Support compilation of aggregate reports by providing requested EMR specific data
- Participate in global PV training activities
- Manage PV training for local affiliate employees incl. sales representatives as applicable
- Support labeling update activities
- Support Direct Healthcare Professional Communication and other risk minimisation measures, if applicable
- Perform/organize local literature search (journals not listed in EMBASE); maintain, check and update list, documentation of local literature search
- Keep senior managers updated of changes in local responsible persons
- Keep local PV SOP updated on a regular basis
- Act as local contact point for audit and inspections and related processes, including the preparation and maintenance of Inspection Binder
- Support review of local agreements and compliance
- To ensure appropriate archiving of relevant documentation and correspondence
- To represent GPRM and the company in an ethical and positive manner
- Work independently and responsibly in occasional work from home environment
Work Environment:
- Voluntary medical insurance
Requirements:
- Minimum 2-4 years of working experience in pharmaceutical industry
- Minimum 2-4 years of experience performing the functions of pharmacovigilance or materiovigilance, including review and reporting of adverse events, communication with Health Authorities/notified bodies
- Degree in Medical Science strongly preferred or Pharmacist, Life Sciences degree
- Knowledge of EMR laws and guidelines related to medicinal products and medical devices
- Good spoken and written English knowledge, including medical terminology
- Basic computer literacy, including Excel and PowerPoint
- Analytical thinking and problem-solving skills
- Excellent interpersonal and presentation skills
- Strong patient orientation
Откликнуться на эту вакансию: Local Pharmacovigilance Manager
Предыдущая вакансия:
Вакансия № 5025528 на должность Менеджер по работе с ЛПУ от компании ООО ГК АСТИ в городе (населенном пункте) Москва