Drug Safety Manager

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:

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

Requirements:

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

Why work at Asphalion?

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