We offer 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 are looking to make a difference in people's lives, we invite you to join us! We are hiring a full-time PV Specialist who will monitor and report adverse events and safety information, ensuring compliance with regulatory safety guidelines and conducting activities to monitor and enhance the safety profile of Medisons products.
Responsibilities:
* Receiving, translating, processing and documenting any reports, from overseas or locally, regarding adverse events and safety information of our 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 pharmaceutical 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
* Participating in preparations for PV audits and inspections.
* Conducting PV trainings to our employees and external suppliers.
City:
Petah Tikva
Requirements: * BA in Pharmacy + valid Pharmacist license - Advantage, or BA in Life Sciences
* Fluency in English, both written and spoken
* Proficient in Microsoft office (Word, Power Point, Outlook and Excel)
* Excellent communication skills, both written and verbal
* Attention to detail and 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 attention to detail
* Ability to work under pressure and meet deadlines in a fast-paced environment
* 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
This position is open to all candidates.