J&J Family of Companies Local Safety Officer in Ljubljana, Slovenia
At Janssen, 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.
Local Safety Officer
Location: Ljubljana, Slovenia
Contract: fixed term contract for 1 year
Act as LSO for Janssen Cilag medicinal products and Johnson & Johnson Consumer products (OTC medicinal products, Consumer medical devices and cosmetics).
Contact Person for Pharmacovigilance
Have sufficient competences to influence the implementation of a system of quality and activity of pharmacovigilance;
Have an overview of the safety profiles of medicinal products, medical devices and cosmetics and safety issues and shall observe and monitor the conditions of marketing authorizations and other obligations pertaining to the safety of medicinal products, medical devices and cosmetics and measures for reducing risk;
Take appropriate measures to ensure that new safety information is available to Health Care Professionals (HCP) in a timely manner.
Collaborate with Regulatory Affairs to forward any safety-related inquiry or relevant communication from the local RA to the appropriate global and regional groups as appropriate.
Assist inspectors / auditors; support document requests.
Evaluation of scientific safety data for impact on any specific local regulatory requirements including labeling data as applicable.
Local safety activities to ensure that specified timelines and reporting requirements are met.
Act as a Business Quality back-up on demand
Assists in maintaining and monitoring quality systems and procedures for pharmacovigilance to assure regulatory compliance with global government and local regulations relative to pharmacovigilance.
Crucial requirements for candidates:
Experience on the similar position;
University degree (preferably in medical studies);
Fluent English and Slovenian;
High analytical skills to provide data analyses with recommendations
Ability to work independently and in a team;
Ability to manage time, adapt and react to dynamic and changing circumstances;
High level of energy, engagement and responsibility;
Ethical approach in achieving goals;
Very good computer skills (Microsoft Office – Word, Excel, Power Point);
Work in cross-functional teams
J&J contract for 1 year
An opportunity to be part of a global market leading company
A dynamic and inspiring working environment
Possibilities for further personal as well as professional development
Motivating financial remuneration
Numerous employee benefits
Johnson & Johnson d.o.o (7397)