Regulatory Affairs Technician & Local Product Safety Officer
Location: BelgiumSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Pharmaceutical organization, based in Brussel Belgium.
The client provide's complete skin treatment solutions at different levels: cure, prevention and care.
ROLE DESCRIPTION
To assume, with the Corporate Regulatory Affairs Manager, the technical responsibility of all the medicines, cosmetics and medical devices already registered in the country to maintain them nationally.
RESPONSIBILITIES
Regulatory Affairs:
•To validate from a regulatory point of view. the texts and packagings of products to be marketed in French speaking countries.
•To know and execute the General Safety rules, Environment rules.
•To evaluate licensing deals from a technical point of view.
•To keep an updated knowledge of the regulations published in the field of pharmaceutical matters.
•Batch release in the local market.
Local Product Safety Officer (Pharmacovigilance):
•Working in conjunction with Corporate Product Safety
•The writing and maintaining of local procedures covering vigilance and adverse event case management activities.
•Ensures Corporate Product Safety is kept up to on vigilance activities conducted at a local level via the appropriate tools.
REQUIREMENTS
• Education: University Degree in Pharmacy or similar.
• Experience: At least 2 years of experience in Regulatory Affairs
• Languages: English, French, Dutch.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees van Wezel.
