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Lead Pharmacovigilance Specialist

hace 1 semana


Madrid, Madrid, España ASPHALION A tiempo completo
Job Description

At Asphalion, we are committed to advancing patient safety through innovative pharmacovigilance solutions. As a Lead Pharmacovigilance Specialist, you will play a pivotal role in shaping our team's approach to vigilance project management.

Main Responsibilities
  • Elevate Patient Safety by orchestrating a symphony of vigilance, ensuring every note of our pharmacovigilance projects resonates with precision and care.
  • Master the handling of Individual Case Safety Reports (ICSRs) and conduct diligent follow-ups, safeguarding patient well-being.
  • Streamline the processing of cases through our own 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 robust Pharmacovigilance Systems (SOPs).
  • Conduct thorough pharmacovigilance audits, ensuring compliance and maintaining the integrity of client PV systems.
  • Provide unwavering support to EU-QPPV and local person for PV in Spain, ensuring highest standards of patient safety across the European Union.
  • Craft comprehensive Periodic Safety Update Reports (PSURs), Risk Management Plans (RMP), ACOs, DSUR.


Requirements
  • 5 years experience in Pharmacovigilance departments.
  • 2 years experience in Team Management & Project Management.
  • Fluent in English & Spanish.
  • 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.


About Working at Asphalion
  • Permanent contract.
  • Flexible working schedule - Friday until 15:30h.
  • Home office & Hybrid or Remote Model.
  • Wide variety of projects, new challenges, and experiences.
  • Training and personal development program.
  • English lessons.
  • A professional, inclusive, and high-performance work environment.
  • A great company culture built around Passion, Flexibility, Commitment, Quality & Companionship.
  • A highly dynamic working environment with employees from more than 15 nationalities.
  • Our people and their well-being are our priority.