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 :

• 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 :

Why working at Asphalion?

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