Drug Safety Manager

ASPHALION; Granada; Híbrido; EUR 40.000 - 80.000; Jornada completa

Descripción de la vacante

An innovative firm is seeking a Drug Safety Manager to lead pharmacovigilance efforts and inspire a dedicated team focused on patient safety. This role involves managing Individual Case Safety Reports, conducting literature reviews, and ensuring compliance with evolving regulations. The position offers a permanent contract with the flexibility of a home office or hybrid model, allowing you to work from anywhere in Spain. Join this dynamic environment where you'll tackle diverse projects and engage in continuous personal development, making a real impact on patient safety across Europe.

Servicios

Permanent contract

Homeoffice & Hybrid or Remote Model

Training and personal development program

Formación

• 5+ years in Pharmacovigilance with team and project management experience.
• Proven ability in literature reviews and case reporting.

Responsabilidades

• Lead pharmacovigilance project management and team oversight.
• Conduct literature reviews and manage Individual Case Safety Reports.

Conocimientos

Pharmacovigilance

Team Management

Project Management

Communication Skills

Attention to Detail

Literature Review

Educación

Academic Degree in Life Science

Pharmacovigilance Certification

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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