Asphalion is an International Scientific and Regulatory Affairs consultancy, with offices in Barcelona, Madrid, Pamplona, Londres, and Munich.
We offer comprehensive services for Drug Development and Regulatory Affairs to Pharma, Biotech, and Medical Devices companies.
Since 2000, we have consistently grown and now have over 110 professional consultants with backgrounds in Life sciences (Pharmacy, Chemistry, Biology, Biochemistry, Biotechnology, Medicine, and Veterinary Medicine).
Our consultants are experts in their field and are in direct contact with EU agencies (EMA and NCAs) for the development and implementation of new regulatory standards.
Asphalion provides a global range of services, for global clients.
Our services range from early development, throughout the registration, until marketing and post-commercialization phases of your product.
Through our network of regulatory consultants, Asphalion is in a position to support your worldwide scientific & regulatory activities.
We make use of a dedicated US agent in the fields of Pharma/Biotech, Medical Devices, and In Vitro Diagnostics.
Functions/Key Activities
In the Pharmacovigilance Department, you will learn and give support to the team in the following tasks:
* Weekly global or local literature review
* Handling of ICSRs and follow-up
* Contact with the Spanish Regulatory Authorities
* Assistance as Qualified local contact in Spain for pharmacovigilance
* Keep Client informed about local pharmacovigilance legislation
* Informing and updating the company about all changes regarding the requirements of the local Regulatory Authorities
* Maintenance of PSMF and Asphalion Pharmacovigilance System (SOPs)
* Preparation of PSURs, RMP, PSMF, CCSI
* Reporting of cases to the European authorities through EudraVigilance
* Case processing of non-serious cases through database
Profile:
* Bachelor’s degree
* Master’s degree - Currently studying
* Intermediate or high level of English, spoken and written
* Excellent computer skills
We offer you:
* Duration: 9 months - 1 year
* Schedule: Flexible, around 8 to 17h (Monday – Thursday) & 8 to 15h Friday
* Offices: PAMPLONA, hybrid model
* Social benefits: English lessons & Wellbeing programme
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