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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 25 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 are looking to make a difference in people's lives, we invite you to join us! We are hiring PV Associate. Monitoring and reporting adverse events and safety information, ensuring compliance with regulatory safety guidelines and conducting activities to monitor and enhance the safety profile of Medison’s products

Responsibilities:

* Receiving, translating, processing and documenting any reports, from overseas or locally, regarding adverse events and safety information of Medison’s products in compliance with regulatory requirements
* Submitting timely and accurately safety reports to the Ministry of Health in compliance with local regulatory requirements
* Actively following-up on adverse events reported by physicians and patients
* Collecting and reviewing safety and efficacy measures taken by health authorities in recognized countries. This includes monitoring publications, regulatory updates, and safety communications from agencies such as the FDA, EMA, and other global health organizations to ensure compliance and up-to-date safety practices for Medison’s products
* Reviewing relevant data from the scientific literature related to drug safety. This includes conducting literature searches to identify new safety information, adverse events, and emerging safety issues
* Promoting awareness among healthcare professionals and medical teams regarding the importance of reporting adverse events to ensure public safety
* Conducting periodic internal and external reconciliations
* Assisting in preparation for PV audits and inspections
* Conducting PV trainings to Medison’s employees and external suppliers
* Additional tasks as defined by the manager