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:
1. Weekly Global and Local Literature Review: Conducting meticulous weekly literature reviews, both globally and locally, to stay ahead of safety insights.
2. Case Management: Mastering the handling of Individual Case Safety Reports (ICSRs) and diligent follow-ups, safeguarding patient well-being.
3. Management Global Safety Database: Streamlining the processing of cases through our own database, ensuring every detail is captured.
4. EudraVigilance Reporting: Reporting cases to European authorities with accuracy and efficiency.
5. Communication with Competent Authorities: Engaging with Competent Authorities, serving as a pivotal point of contact.
6. Regulatory Intelligence: Keeping our clients and company abreast of the evolving global and local pharmacovigilance legislation and authority requirements.
7. PSMF and PV SOPs: Overseeing the maintenance of the PSMF and Asphalion's robust Pharmacovigilance System (SOPs).
8. PV Audits: Conducting thorough pharmacovigilance audits, ensuring compliance and maintaining the integrity of client's PV system.
9. 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.
10. Aggregate Safety Reports: Crafting comprehensive Periodic Safety Update Reports (PSURs), Risk Management Plans (RMP), ACOs, DSUR.
11. Medical Advisory: Providing insightful advice, shaping the efficiency in drug safety.
12. PV Agreements: Drafting meticulous Pharmacovigilance contracts that set the standard for collaboration.
Requirements:
1. 5 years experience in Pharmacovigilance departments.
2. 2 years experience in Team Management & Project Management.
3. Previous experience working in an international environment.
4. Academic Degree in Life Science and Pharmacovigilance.
5. Advanced IT level – (MS Office).
6. Proactive, good communication, accurate, detail oriented.
Why Work at Asphalion?
1. Permanent contract.
2. Homeoffice & Hybrid or Remote Model (You can be located anywhere in Spain!)
3. Wide variety of projects, new challenges and experiences.
4. Training and personal development program.
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