Job Description

Job Summary:

A Product License Maintenance Manager will ensure Pfizer maintains compliance by delivering the portfolio of one or

multiple applicable regulatory obligations. The PLM Manager \xe2\x80\x93 Article 57/3rd Acknowledgement Medra Coder role will work across team/s whose focus will be to comply with data submission activity including XEVMPD,3rd Acknowledgement medra coding edit support and also support to IDMP implementation. 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, in support of EEA markets, team members will be accountable for partnering with appropriate stakeholders in submission of A57 records to the EMA . The PLM manager will have a deep understanding of the MedDRA (Medical Dictionary for Regulatory Activities) coding system and a strong background in medical coding. This also includes crucial role in ensuring accurate and consistent coding of regulatory events and medical terms in accordance with regulatory standards.

Job Responsibilities:

PLMDS Senior Associate

• Has fundamental understanding of XEVMPD and IDMP requirements and regulations
• Conduct MedDRA coding at the 3rd Acknowledgement level, QA & edits as applicable.
• Medra coding of Co-Morbidity and selection of Intended Effect
• Stay current with updates and changes in the MedDRA system, specifically related to 3rd Acknowledgement
• Participate in quality control processes to maintain data accuracy and compliance
• Provide expertise and guidance on 3rd Acknowledgement coding-related queries
• Support/Lead the maintenance of the following IDMP specific Name Part fields: Trademark, Formulation Flavour, Intended Use, Target Population, Container or Pack, Device, Time/Period & Delimiter
• Stay updated on changes and updates to the MedDRA system and other relevant coding standards
• Participate in training sessions and contribute to the development of coding procedures
• Develop operational and governance models to support readiness activities for new data focused regulatory obligations (e.g., 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
• Lead and support projects, developing tactical approach including timelines, works plans and deliverables for moderately complex activity
• Design and implement new solutions through stakeholder partnerships, ensuring ability to maintain compliance and data integrity, continuously improving on those processes.

Skills (Required):

• Bachelor\xe2\x80\x99s Degree with relevant experience
• Knowledge of other structured data requirements/regulations and EU Telematics projects (e.g., SPL, PQ CMC, IRIS, ePI, DADI, etc.)
• Trained in MedDRA coding or have Certification in medical coding (e.g., Certified Clinical Coder)
• Familiarity with EU/US FDAregulatory standards
• Proficiency in using coding software and databases
• 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, Power BI), etc.
• 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)
• Demonstrated project and change management skills; competent illustration of processes, tools and techniques for planning, monitoring, and implementing multiple projects to established deadlines
• Demonstrated ability to take responsibility, solve problems and deliver in a challenging, fast-paced environment
• Demonstrated ability to function autonomously in a matrix environment, working independently with minimal input from peers

Skills (Preferred):

• 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
• Proven experience as a Medra Coder in the pharmaceutical or clinical research industry
• Demonstrated experience of influencing through data storytelling, with the ability to use data to inform on an idea, concept, or insight
• Knowledge of XEVMPD and IDMP
• Experience in registering XEVMPD and SPOR data
• Knowledge of European regulatory framework including structure and content of Summary or Product Characteristics (SmPC) and Chemistry Manufacturing and Controls (Module 3)
• Able to operate at pace with agile decision-making skills; use evidence and apply judgment to balance pace, rigor, and risk
• Ability to apply critical thinking through reasoned judgements that are logical and well-thought out
• Able to respond to challenges with an adaptive mindset, seeing them as opportunities to innovate and improve

Qualifications

Must-Have

• Bachelor\'s Degree
• 5+ years of experience
• Experience in project management
• Relevant experience in electronic submissions build within the Pharmaceutical Industry
• Strong knowledge of the drug development process, regulatory affairs, and submission management
• Understanding of systems and electronic technologies used to support submission and planning activities
• Attention to detail and exceptional organizational skills
• Presents scientific data effectively, in verbal and written in a logical and persuasive manner
• Proven experience managing or delivering through others in a team environment
• Proficient in English, verbal and written

Nice-to-Have

• Master\'s degree
• Relevant pharmaceutical experience
• Familiarity with pharmaceutical organizational structures, systems, and culture
• PMP or other similar certification

Work Location Assignment: Flexible

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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