J&J Family of Companies LOCAL SAFETY SPECIALIST in Budapest, Hungary
At Janssen, part of Johnson & Johnson, Family of Companies, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson. Please visit www.janssen.com for more information.
LOCAL SAFETY SPECIALIST
Full time temporary contract till 30.09.2019
Supporting the Local Operating Company Pharmacovigilance activities are managed in compliance with local regulations and company policies/procedures at a local, regional and global level and in accordance with any Pharmacovigilance agreements with third party business partners.
- Case Processing:
-Support the coordination of safety reporting requirements as required for MAH and/or study sponsor, as applicable.
-Responsible for the collection, review and reporting of Adverse Events (AEs), AEs combined with Product Quality Complaints (AEs +PQCs) and pregnancy reports obtained through the following sources: spontaneous, solicited, clinical studies, data generating activities, Local Regulatory Authorities (RAs) and other potential sources e.g. Literature sources.
Translation of ICSR, PSUR, HA correspondence, regulatory intelligence, as required.
Assist with initial quality review and assessment of individual cases.
Co-ordinate/perform the follow-up of missing information from the AE reporter.
Support LSO (Local Safety Officer) to the submission of Development Safety Update Reports (DSURs), providing due dates to the Global Medical Organization (GMO) and promoting synchronization with global aggregate reporting schedules, in accordance with national requirements and in collaboration with the local Regulatory Affairs unit.
Assist in the provision of local data as required supporting the preparation of aggregate reports.
Act as a back-up Local Safety Officer, whenever needed.
University or Collage degree in Medical field
2 – 4 Years of experience in Pharmacovigilance
Knowledge and background in Medical field
Good spoken and written English, fluent level of Hungarian
Proactive and “can do” attitude
Good communication skills and assertively
Sense of urgency; problem solving abilities with focus on solutions
An opportunity to be part of a global market leader
A dynamic and inspiring working environment
Many opportunities to work on challenging projects and assignments
Possibilities for further personal as well as professional development
Motivating financial remuneration
Other employee benefits
If you are interested in this role and you fulfill the requirements set above, do not hesitate to send us your CV and cover letter in English
Janssen-Cilag Kft. (8396)