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:

Elevate Patient Safety & Lead with Excellence as a Drug Safety Manager, you will orchestrate a symphony of vigilance, ensuring that every note of our pharmacovigilance projects resonates with precision and care. Your expertise will be the beacon guiding our team through of:

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

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 orientated

Why working at Asphalion?

️Permanent contract.

Flexible working schedule - Friday until 15.30h.

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.

English lessons.

A professional, inclusive and high-performance work environment to develop your skills and grow your career. 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: Physical, psychological and emotional well-being programme.

Internal activities & RSC Activities

Equal Opportunity Employee