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

Litens Automotive GmbH & Co. KG; Madrid; Presencial; EUR 60.000 - 85.000; Jornada completa

Descripción de la vacante

A leading European specialty pharmaceutical company is seeking a Global Pharmacovigilance Senior Scientist in Barcelona. This hybrid role involves supporting safety management and ensuring compliance with local and global regulations. The ideal candidate will have extensive experience in pharmacovigilance and a relevant degree in life sciences.

Formación

• At least 5 years of experience in pharmacovigilance.
• Experience in local, regional, and global safety regulations.

Responsabilidades

• Support safety management activities for all products.
• Monitor execution of activities delegated to Global PV vendor.
• Review periodic safety reports and risk management plans.

Conocimientos

Pharmacovigilance

Signal Detection

Regulatory Compliance

Educación

Bachelor’s or master’s degree in life sciences

Herramientas

MS Word

MS Excel

MS Access

MS Outlook

Descripción del empleo

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).

J-18808-Ljbffr

J-18808-Ljbffr