לוח משרות דרושים רוקחות ופארמה משרה מלאה

In Research and Development, we're full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a cleaner, healthier world. With nine Centres of Excellence, we continually seek out new opportunities by using science, our entrepreneurial flare and our fearless innovation to develop and enhance our existing portfolio, never compromising on quality or performance.

We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality.

The size of our organisation means you'll have the opportunity to learn and work in different functions within R&D, giving you exposure to different disciplines, teams and environments. You will also have access to our Research and Development Academy, designed to develop our team and allow you to grow in our great organisation.
About the role
The primary responsibility of the Commercial Quality Manager & QP Israel is to provide leadership for excellence in Quality and Compliance of all Reckitt products and processes within the Israelian Commercial Business Unit. Youll:

Ensure a robust Quality Management system is in place and fit for purpose to comply with current regulations such as relevant GMP and GDP and Israelian Health Authorities requirements
Lead and facilitate quality continuous improvement activities
Implement processes and procedures and observe/audit for compliance
Provide feedback to the Commercial Quality SE manager on performance
Serve as a resource for information relative to all aspects of products and process quality
Implement and enhance culture of Quality
Final batch certification and release to the Israelian market
Maintain the validity of the GMP license
Ensure product safety and regulatory compliance
Co-ordinate and host external inspections by External Authorities, third parties and Reckitt.

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

The Regulatory Affairs Post-Market Specialist leads and executes key post-market activities to ensure compliance with the Israeli Ministry of Health (AMAR) and requirements. This includes managing adverse event (vigilance) reporting, coordinating Field Safety Corrective Actions (FSCAs), and serving as a regulatory contact for post-market issues in Israel. The role involves close collaboration with cross-functional and global teams to maintain the highest standards of quality and patient safety.

Responsibilities may include the following and other duties may be assigned:

Lead the execution and follow-up of Field Safety Corrective Actions (FSCAs) including coordination with internal teams, customers, and submission to the Ministry of Health (MOH)
Manage the adverse event (vigilance) reporting process to the Israeli MOH, ensuring timely and accurate submissions in accordance with local regulatory timelines and guidelines
Collaborate closely with internal stakeholders including global post market teams to ensure consistent and compliant execution of post-market activities
Serve as a regulatory contact for the Israeli MOH on all post-market issues, including adverse events, recalls, field actions, and periodic updates
Stay up to date with changes in AMAR regulations, MOH guidelines, and industry standards, and communicate potential impacts to management and relevant teams
Participate in the local recall committee or crisis response team in the event of product safety issues requiring urgent action
Provide training to local teams on vigilance reporting, complaint handling, and FSCA procedures to ensure consistent and compliant practices

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