6 Smpc Jobs

Description Author / update labelling documents such as EU SmPC, regional PIs. Act as the first layer of quality check for draft labelling documents. Ad hoc EU Proofing of Baseline English, QRD Formatting Review. Provide proofreading support for labelling documents against Health Authority regulations, ensuring timelines are met, the submissions are agency compliant and of quality. Formatting, technical / scientific content check, alignment to regional templates, client reference guide regular monitoring and tracking of Innovator labels. Review labels for compliance with applicable regulations and policies. Linguistic review of EU SmPC revisions and Support EU readability testing Review / QC...

As the Senior Manager of Patient Safety at ADVANZ PHARMA, your primary responsibility will be to monitor and manage all aspects of updating Reference Safety Documents for all ADVANZ PHARMA products globally. You will need to maintain these documents in accordance with applicable guidelines, ensuring a global process along with region-specific processes for writing and managing reference safety documents like CCDS and SmPC. Your experience in writing reference safety documents for various types of drugs will be crucial for this role. **Key Responsibilities:** - Act as a subject matter expert in global labeling requirements, driving continuous improvement initiatives, and upholding high-qualit...

Role & responsibilities Labeling Responsible for creating and updating compliant English product information for EU procedures. Providing instructions and guidance to local RA (e.g. calculations due to new excipients warnings). Discussion of the content of product information for innovative products (pre- and post-approval) in project teams. Evaluate and approve change requests; coordinate submissions with EU regulatory units. Collaborate on patent-related issues with Global IP Group. Contribute to readability studies and ensure PIL readability and compliance with legal requirements. Adaption to reference medicinal product (generic, hybrid, biosimilar procedures). Preparation of Expert state...

Role & responsibilities The responsibilities of the role include processing Individual Case Safety Reports (ICSRs) and conducting literature screening activities. The candidate will be responsible for reviewing and assessing the validity of literature abstracts and articles, with further processing into the safety database as required. Additionally, the role involves maintaining the Extended Eudravigilance Medical Product Dictionary (XEVMPD) and performing EVWEB updates, including revisions to the Summary of Product Characteristics (SPC/SmPC) and Patient Information Leaflets (PILs). The candidate will also perform comparative reviews of SmPC and PIL documents against reference products. A ke...

Role & responsibilities We are seeking a Pharmacovigilance Associate with 2 to 3 years of experience in the pharmaceutical industry. The ideal candidate should have hands-on experience in processing Individual Case Safety Reports (ICSRs) and performing literature screening to identify safety information. This includes assessing validity of literature abstracts/articles for database entry. The role also involves maintaining XEVMPD, performing EVWEB updates, revising SmPCs, PILs, and preparing Risk Management Plans (RMPs). Monitoring safety updates/signals and ensuring SOP & regulatory compliance is essential. Preferred candidate profile Eudravigilance, XEVMPD Maintenance, EVWEB Updates, SmPC ...

Role & responsibilities Develop US labeling documents to align with company goals and submission requirements for assigned ANDAs and/or 505(b)(2)s, if required, and ensure labeling meets all legal and regulatory requirements. This includes QC, proofing, editing, and formatting of documents, and coordinating the review and approval of final submission documents. Develop US labeling documents needed for early development projects requiring a human factor or comparative analysis study and ensure established labeling meets all legal and regulatory requirements. This includes QC, proofing, editing, and formatting of documents, and coordinating the review and approval of final submission documents...