Appointed Pharmacist応募後で応募 求人ID R0032164 掲載日 06/15/2021 Location:Petah Tikva, Israel
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Appointed Pharmacist in Israel.
At Takeda, we are transforming the pharmaceutical industry through our R&D- driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
Activities and Responsibilities
- Approving materials for HCP and Patients including submission of requests for raising illness awareness Campaign and materials for assuring patients treatment compliance (including PSP materials) according to current local regulatory guidelines
- Submissions of new drug applications of a pharmaceutical product to the Control and Standards of Medicine product Institute and Medicine Registration of the Ministry of Health. The Appointed Pharmacist will make sure the application is in accordance to all regulation and SOPs of the Ministry of Health as for the structure and content.
- Submissions of renewal applications of a pharmaceutical product to the control and Standards of Medicine product Institute and Medicine Registration of the Ministry of Health. The Appointed Pharmacist will make sure the application is in accordance to all regulation and SOPs of the Ministry of Health as for the structure and content.
- Submissions of CMC variations applications of a pharmaceutical product to the Control and Standards of Medicine product Institute and Medicine Registration of the Ministry of Health. The Appointed Pharmacist responsible to update all relevant people such as Qualified Person, marketing, Supply Chain Manager etc.) on pending and approvals to variations and changes relating to manufacturing.
- Submission of requests for advertising of OTC and Rx drugs and assure advertising compliance
- Submission of updates to label (physician PI / patient inserts) and assure implementation in marketed product. In addition, the Appointed Pharmacist will inform pharmacists and physician regarding relevant information concerning changes in label.
- Submission of updates to artwork (carton, label, blister, leaflet etc) and assure implementation in marketed product. In addition, the Appointed Pharmacist will inform pharmacists and physician regarding relevant information concerning changes in artwork
- Provide the Qualified Person with the most up-to-date product registration documentation and approved packaging materials. In addition, the Appointed Pharmacist must keep the Qualified Person updated with expected variation to the registration documentation including but not limited to CMC part and labelling. The Appointed Pharmacist must also notify the Qualified Person with information which might affect the decision to release/reject a batch of a registered product including but not limited to its safe and effective use
- Submission for inclusion or removal from National Health Basket list (reimbursement).
- Providing answers to any questions raised by the Ministry of Health
Skills and Competencies
- The appointed pharmacist should have vast experience regarding 134 and 137 SOP's
- The Appointed Pharmacist must be well acquainted and have vast experience and knowledge of all the laws, regulations, guidelines, circulars, and current requirements of the Israeli Ministry of Health.
- He/ She must also be proficient and have vast body of knowledge regarding the quality, safety, control, and efficacy related to his products.
- Highly organized and structured
- Good communication, problem solving and time management skills. Able to prioritize workload to make the most of time and resources
- English must be fluent