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: Orchestrate a symphony of vigilance, ensuring that every note of our pharmacovigilance projects resonates with precision and care.
* Weekly Global and Local Literature Review: Conduct meticulous weekly literature reviews to stay ahead of safety insights.
* Case Management: Master the handling of Individual Case Safety Reports (ICSRs) and diligent follow-ups, safeguarding patient well-being.
* Management of Global Safety Database: Streamline the processing of cases through our database, ensuring every detail is captured.
* EudraVigilance Reporting: Report cases to European authorities with accuracy and efficiency.
* Communication with Competent Authorities: Engage with Competent Authorities, serving as a pivotal point of contact.
* Regulatory Intelligence: Keep our clients and company abreast of evolving global and local pharmacovigilance legislation and authority requirements.
* PSMF and PV SOPs: Oversee the maintenance of the PSMF and Asphalion's robust Pharmacovigilance System (SOPs).
* PV Audits: Conduct thorough pharmacovigilance audits, ensuring compliance and maintaining the integrity of the client's PV system.
* EU-QPPV and Local Person for PV in Spain Support: Provide 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: Craft comprehensive Periodic Safety Update Reports (PSURs), Risk Management Plans (RMP), ACOs, and DSUR.
* Medical Advisory: Provide insightful advice, shaping the efficiency in drug safety.
* PV Agreements: Draft meticulous Pharmacovigilance contracts that set the standard for collaboration.
Requirements:
* 5 years experience in Pharmacovigilance departments.
* 2 years experience in Team Management & Project Management.
* 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.
Why work at Asphalion?
* Permanent contract.
* 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.
* 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 program.
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