לוח משרות דרושים רפואה ופארמה

What you will be doing:
* Be part of the company management team with responsibility to lead regulatory strategy planning for company products.
* Responsible to prepare regulatory submissions across all products and platforms as needed.
* Review and present to the management and CEO regulatory updates and status reports.
* Responsible for the development and preparations of regulatory submissions across all products and platforms as needed.
* Be the point of contact for all regulatory inputs and deliverables from headquarters for product and clinical research submissions.
* Responsible for maintenance of product regulatory files and registrations (NoC, registration renewals, annual reports etc.).
* Provide regulatory support to R&D - project regulatory requirements, assure adherence to the regulatory path and resolve emerging conflicts with regulatory requirements.
* Responsible to provide regulatory support to manufacturing, logistics, engineering, supply chain and sales teams.
* Responsible for regulatory assessment of customer complaints, reportability assessments and MDR’s to regulatory agencies.
* Act * as the person responsible for regulatory compliance (PRRC), responsible to ensure the following:
* The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
* All post market surveillance and reporting obligations are met, including reporting of serious incidents and field safety corrective actions, trend reporting, analysis of serious incidents and field safety corrective actions and analysis of vigilance data.
* For investigational devices projects , the statement referred to in Section 4.1 of Chapter II of Annex XV of the EU medical device regulation (MDR) is issued. * This is a joint responsibility with VP of Global QA, where VP RA is the main responsible for the above activities

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 are looking to make a difference in people's lives, we invite you to join us! We are hiring a temporary PV Associate for a 9-month maternity leave cover 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 Medisons 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 Medisons employees and external suppliers.

City:
Petah Tikva