Drug Safety Manager

buscojobs España; Alicante; A distancia; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

Join a leading company as a Drug Safety Manager, where you'll oversee pharmacovigilance project management and ensure patient safety. You'll lead a dedicated team, conduct audits, and maintain compliance with evolving regulations, all while enjoying a flexible working model across Spain.

Servicios

Permanent contract

Homeoffice & Hybrid or Remote Model

Training and personal development program

Formación

• 5 years experience in Pharmacovigilance departments.
• 2 years experience in Team Management & Project Management.

Responsabilidades

• Conducting weekly literature reviews for safety insights.
• Handling Individual Case Safety Reports (ICSRs) and follow-ups.
• Reporting cases to European authorities accurately.

Conocimientos

Communication

Attention to Detail

Proactivity

Educación

Academic Degree in Life Science

Pharmacovigilance

Herramientas

MS Office

Descripción del empleo

Join our trailblazing team as a Drug Safety Manager, where you'll lead the charge in pharmacovigilance project management and inspire a team dedicated to advancing in patient safety.

Main Responsibilities :

• Conducting meticulous weekly literature reviews, both globally and locally, to stay ahead of safety insights.
• Mastering the handling of Individual Case Safety Reports (ICSRs) and diligent follow-ups, safeguarding patient well-being.
• Streamlining the processing of cases through our own database, ensuring every detail is captured.
• Reporting cases to European authorities with accuracy and efficiency.
• Engaging with Competent Authorities, serving as a pivotal point of contact.
• Keeping our clients and company abreast of the evolving global and local pharmacovigilance legislation and authority requirements.
• Overseeing the maintenance of the PSMF and Asphalion's robust Pharmacovigilance System (SOPs).
• Conducting thorough pharmacovigilance audits, ensuring compliance and maintaining the integrity of client’s PV system.
• Providing unwavering support to the EU-QPPV and local person for PV in Spain, ensuring the highest standards of patient safety across the European Union.
• Crafting comprehensive Periodic Safety Update Reports (PSURs), Risk Management Plans (RMP), ACOs, and DSUR.
• Providing insightful advice, shaping the efficiency in drug safety.
• Drafting meticulous Pharmacovigilance contracts that set the standard for collaboration.

Requirements :

• 5 years experience in Pharmacovigilance departments.
• 2 years experience in Team Management & Project Management.
• Previous experience working in an international environment.
• Academic Degree in Life Science and Pharmacovigilance.
• Advanced IT level – (MS Office).
• Proactive, good communication, accurate, detail-oriented.

Why Work at Asphalion?

• Permanent contract.
• Homeoffice & Hybrid or Remote Model (You can be located anywhere in Spain!).
• Wide variety of projects, new challenges, and experiences.
• Training and personal development program.

J-18808-Ljbffr