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Open nowPosted yesterday

Специалист по фармаконадзору

АО "ФАРМАСИНТЕЗ-НОРД"

Where
Санкт-Петербург, Russia
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Your applicationOpen nowСпециалист по фармаконадзоруАО "ФАРМАСИНТЕЗ-НОРД" · Санкт-Петербург, Russia

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on АО "ФАРМАСИНТЕЗ-НОРД"'s own form.

The reply lands in your private mailbox

3×more interviews than doing it yourself with ChatGPT.

The clock on this job

Early applications get read.

12.4% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.4%7 days
  4. 20.0%14 days
  5. 35.5%30 days
  6. 58.6%60 days
This job: posted yesterday

The posting

Полное ведение процесса информирования регуляторных органов о безопасности лекарственных средств в соответствии международными и российскими требованиями (подготовка и передача информации о нежелательных побочных реакциях) Внесение, кодирование и актуализация информации о НПР в электронной системе учёта Информационное взаимодействие по нежелательным явлениям с локальными регуляторными органами, контрактными организациями и другими подразделениями компании Разработка и обновление процедур управления рисками в соответствии с изменениями требований регуляторных органов, участие в инспекциях регуляторных органов и аудитах внутри компании Составление графиков предоставления периодических отчётов по безопасности лекарственных препаратов (ПООБ), планов управления рисками (ПУР) Подготовка им передача отчётов по фармаконадзору, планов управления рисками в Федеральный центр мониторинга безопасности лекарственных средств РФ Проведение работы с жалобами потребителей Проведение обучения сотрудников предприятия по фармакологической безопасности Подготовка полугодовых и ежегодных отчётов о проделанной работе

Высшее медицинское образование, желательно дополнительное образование в области фармаконадзора, клинической фармакологии, биостатистики Знание законодательства в области фармаконадзора, регистрации лекарственных средств, клинических исследований лекарственных средств Опыт написания ПООБ, ПУР, клинических обзоров, СОП по фармаконадзору Знание пакета Microsoft Office (Excel, Word, PowerPoint и т.п.), работа в программах по учёту нежелательных реакций, базах данных Ответственность, внимательность, усидчивость, умение работать с большим объёмом информации в режиме многозадачности

Оплата занятий спортом,Оплата питания,Добровольное медицинское страхование,Предоставление служебного транспорта

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