תיאור המשרה
Description Medison offers hope to patients suffering from rare and severe diseases by forming partnerships with emerging biotech companies to accelerate access to highly innovative therapies in international markets. As the creator and leader of the global partnership category in the pharma industry, we strive to be Always Ahead and work relentlessly to bring therapy to patients in need, no matter where they live. Our values are at the core of every action we take, and we are committed to going above and beyond for the benefit of the patients we serve. We are a dynamic, fast-paced company operating in over 30 countries on 5 continents. We are looking for out-of-the-box thinkers, people who are passionate, caring, agile, and adaptive, to join us on our mission. If you want to make a difference in people's lives, we invite you to join us! The QPPV is a senior position within the pharmacovigilance team, responsible for ensuring that Medison complies with all regulatory requirements related to the safety of its medicinal products. The QPPV is the primary point of contact for the Israeli MoH and Medison’s global partners and ensures that Medison meets its legal obligations regarding the monitoring, assessment, and reporting of adverse drug reactions Responsibilities Communicating with the Ministry of Health regarding pharmacovigilance activities, ensuring compliance with local regulations. This includes timely submission of safety reports and responding to inquiries and requests Overseeing the internal PV system, ensuring its effectiveness and continuous improvement, including processes, tools, and personnel Managing the safety agreements with Medison’s global partners and external suppliers, if applicable leading PV audits conducted by Medison’s global partners and inspections conducted by the Ministry of Health Communicating with Medison’s global partners, including participation in periodic meetings, as required Monitoring the compliance of Medison employees with internal procedures, including corrective actions as needed Collaborating with internal departments such as Regulatory Affairs and Medical Affairs to address pharmacovigilance issues Ensuring coordination with the Quality Assurance team to ensure pharmacovigilance processes align with company standards Additional tasks as defined by the manager Requirements Required education and experience A degree in Pharmacy or Medicine, with a valid Israeli license, and with a minimum of two years of experience in their profession Proven experience in Pharmacovigilance, with at least 4 years in a relevant role In-depth knowledge of pharmacovigilance regulations, including local and international standards Fluency in English and Hebrew, both written and spoken Proficiency in Microsoft office (Word, Power Point, Outlook and Excel) Required qualification Excellent communication skills, both written and verbal Attention to detail and the ability to handle complex safety data accurately Ability to work independently and as part of a cross-functional team Ability to manage multiple tasks simultaneously while maintaining high-quality deliverable Ability to work under pressure and meet deadlines Critical thinking and problem-solving skills to identify potential safety issues High level of agility, with the ability to quickly adjust to changing priorities and emerging challenges in a fast-paced environment
