Drug Safety Manager

buscojobs España; Burgos; 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 lead a dedicated team. This role involves ensuring patient safety through meticulous case handling and compliance with evolving regulations. Enjoy a permanent contract with options for home office and hybrid work, alongside opportunities for personal development.

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.
• Mastering Individual Case Safety Reports (ICSRs) handling.
• Reporting cases to European authorities with accuracy.

Conocimientos

Communication

Attention to Detail

Proactivity

Educación

Academic Degree in Life Science and 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.

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