от компании (организации): RB в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Маркетинг"
с заработной платой: по договоренности
Вакансия № 9250453 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Вторник, 8 октября 2024 года.
Дата обновления вакансии № 9250453 на сайте Работа в Москве и Московской области (МО, Подмосковье): Среда, 13 ноября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 9250453 может быть уже занята. Администрация сайта Работа в Москве и Московской области (МО, Подмосковье) приносит извинения за доставленные неудобства.
Требования к опыту работы:
более 6 лет
Тип занятости:
полная занятость
График работы:
полный день
Дополнительные сведения о вакансии: Clinical Operations & Pharmacovigilance Manager
Role Purpose:
Clinical Operations
- Provide leadership and technical support to Clinical Study Teams ensuring the (global) clinical studies are conducted to the required legal, regulatory and quality standards, on time and within established budgets to deliver robust evidence to meet the organisation's annual R&D goals;
- The role implements clinical operational excellence across R&D projects and initiatives through an understanding of project and clinical study requirements compliant with the regulatory framework
- The role focuses on managing multiple studies of varying complexity simultaneously (e.g. human pharmacology, proof of safety; single or multi-site, single or multi-country across all product categories).
- Provide advice on clinical design and operational execution as a Subject Matter Expert for the allocated product categories, study types or techniques/methodologies;
- Provide support on local medical affairs activities and insights to drive medical strategy and external engagement with RB brands.
Pharmacovigilance:
- Ensure that Pharmacovigilance processes are being followed in the local market, whilst liaising with the Global Vigilance Group to ensure alignment of pharmacovigilance processes.
- Ensure local AEs are collected from all sources and reported to the GVG immediately, with anonymized patient data, within the RB assigned reporting timelines, and appropriate follow up is undertaken
- Submit individual case safety reports (ICSRs), Medical Device Incidents and Serious Undesirable Events to the local Competent Authority (CA) as required.
- Ensure all local Third Parties/contractors are aware of their vigilance obligations, and are trained appropriately, with Vigilance agreements in place.
Skills & Experience Required:
- At least 2-4 years (Master degree) or 5-7 years (Bachelor degree) of clinical development experience preferably in a clinical or medical department in pharmaceutical/consumer healthcare/cosmetic industry or at a CRO or clinical vendor;
- An ability to understand, interpret and communicate clinical research data is essential;
- In?depth and up to date knowledge of GCP/regulatory standards;
- Strong understanding of corporate and operational business needs;
- Experienced in process improvement projects including development of Standard Operating Procedures;
- Experience of working closely with commercial colleagues and an understanding of corporate and operational business issues;
- Effective project management and organisational skills;
- Effective medical and scientific writing skills;
- Computer literacy (Advanced Microsoft Skills).
Откликнуться на эту вакансию: Clinical Operations & Pharmacovigilance Manager
Предыдущая вакансия:
Вакансия № 9250440 на должность Водитель-курьер на автомобиль компании от компании Чайхона №1 в городе (населенном пункте) Москва