Job title: PLS Associate-I, A57
Job description: Job Description : Job Summary: The PLS Manager – Article 57 / IDMP role will support Pfizer in delivering the portfolio of one or more applicable regulatory obligations. The role will work across team/s whose focus will be to comply with data submis
Job Description : Job Summary: The PLS Manager – Article 57 / IDMP role will support Pfizer in delivering the portfolio of one or more applicable regulatory obligations. The role will work across team/s whose focus will be to comply with data submission activity including XEVMPD and IDMP. This may include the interpretation of heath authority guidelines, interpretation and transformation of regulatory data, data collection, enrichment, mapping and submission, whilst adhering to all policies, practices, and procedures. In addition, the role may include assisting and/or leading strategic initiatives in support of new and emerging regulatory obligations impacting process, governance and technology and providing subject matter expertise to drive digital transformation. Job Responsibilities: Associate Has fundamental understanding of XEVMPD and IDMP requirements and regulations Uses technical skills to ensure compliance with regulatory obligations including XEVMPD and IDMP Ability to partner with stakeholders across the organization to resolve queries and issues Demonstrates solid grasp in learning, development, and technology Contributes to the completion of project milestones, organizing own work to meet deadlines Work in a structured environment under direct supervision and use established procedures to perform assigned tasks Actively participates in internal and external partnership networks (team meetings, forums, etc.) Assist with routine operational activities including data registration in XEVMPD and SPOR-IDMP Assist with data collection, transformation, mapping, and enrichment from and between documents and systems Assist with data quality reviews to support business objectives (e.g., system data reviews, PSUSA/XEVMPD, and Annual Pharmacovigilance Fees) Knowledge of European regulatory framework including structure and content of Summary or Product Characteristics (SmPC) and Chemistry Manufacturing and Controls (Module 3) Experience and competency with Regulatory software, including RIM applications (e.g., Calyx RIM) and document management systems (e.g., Documentum) Knowledge of technology applications, including Microsoft 365 Apps (e.g., Excel, PowerAutomate, Teams, SharePoint, etc.) Ability to collect, aggregate and map data from and between different documents and systems Strong influencing, engagement, and communication skills (presenting, written, verbal and non-verbal) Qualifications and Skills (Required): Bachelor’s Degree with relevant experience Knowledge of XEVMPD and IDMP Experience in registering XEVMPD and SPOR data Knowledge of other structured data requirements/regulations and EU Telematics projects (e.g., SPL, PQ CMC, IRIS, ePI, DADI, etc.) Experience with coding in MedDRA Ability to work with large datasets, interpret data and draw insights to support data driven approaches, predict outcomes and measure effectiveness Knowledge of data analytics and visualization tools (e.g., Spotfire), etc. Demonstrated experience of influencing through data storytelling, with the ability to use data to inform on an idea, concept, or insight Able to identify and drive digital technology into all areas of a business. Further able to evolve the digital thinking by identifying connections of systems and data across the business Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Regulatory Affairs#LI-PFE
Location: Chennai, Tamil Nadu
Job date: Sat, 05 Feb 2022 23:16:10 GMT
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