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