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Job in Germany : IT Application Developer (m / w / d) Schwerpunkt Solution Architecture

Job in Germany : IT Application Developer (m / w / d) Schwerpunkt Solution Architecture

Litens Automotive GmbH & Co. KGMadrid, Comunidad de Madrid, España
Hace más de 30 días
Descripción del trabajo

Leading European specialty pharmaceutical company focused on the treatment of the CNS built over 35 years is looking for a Global Pharmacovigilance Senior Scientist.

This company is constantly innovating, with new products and solutions to address unmet patient needs and is expanding its portfolio through its pipeline and acquisitions.

This position is based in Barcelona, Sant Joan Despí (hybrid role).

You will report to the Corporate PV Manager.

Responsibilities :

Support safety management activities of all the company’s products.

Carry out PV activities in line with current local and global PV requirements and the company procedures.

Monitor the adequate execution of activities delegated to our Global PV vendor.

Review and make sure that PV contracts (national and international for the group) are up to date.

Review of periodic safety reports and risk management plans prepared for our products worldwide.

Monitoring and oversight of signal detection activities.

Support the creation and implementation of risk minimisation measures, including PV educational materials for our products.

Create standard operating procedures for the PV Department and propose improvements based on your experience.

Ensure that PV activities for the company sponsored clinical trials are in line with company SOPs and applicable regulations.

Participate in the preparation, execution and follow-up of PV audits and / or inspections.

Support the setting up of the PV system for new countries and affiliates.

Minimum Requirements :

At least 5 years of experience within the pharmacovigilance disciplines in the pharmaceutical industry.

Experience in PV related environments, preferably at local, regional and global levels.

Experience in Local / Global safety regulations and standards (e.g. ICH, EU Regulation).

Experience in Clinical Trial EU Regulation.

Knowledge of legislation in force concerning pharmacovigilance.

Advanced level management of MS Word, MS Excel, MS Access and MS Outlook.

Bachelor’s or master’s degree in life sciences (Degree in Pharmacy, Medicine, Biology, Chemistry or similar, Specific training in pharmacovigilance).

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In Germany Developer • Madrid, Comunidad de Madrid, España

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