PLMDS Senior Associate -A57/IDMP

Pfizer

4.1

(94)

Chennai, India

Why you should apply for a job to Pfizer:

  • 4.1/5 in overall job satisfaction
  • 4.6/5 in supportive management
  • 78% say women are treated fairly and equally to men
  • 79% would recommend this company to other women
  • 81% say the CEO supports gender diversity
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • 23-25 Week Maternity Leave (Fully paid for birth parents)
  • Family building benefits include $35,000 fertility services + $25,000 adoption and surrogacy services
  • Pfizer is a founding member of Healthcare Businesswomen's Association Gender Parity Collaborative
  • #4902589

    Position summary

    ions

    • 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)

    Senior Associate (Cumulative from above)

    • Has fundamental understanding of XEVMPD, IDMP and other structured data requirements, regulations and telematic projects (e.g., SPL, PQ CMC, IRIS, ePI, DADI, etc.)

    • Uses technical expertise and experience to deliver on complex tasks and identify new opportunities

    • Develops and uses internal and external partnership networks to influence and improve the accomplishment of business goals

    • Coordinate operational activities to ensure compliance with regulatory obligations including XEVMPD and IDMP

    • Coordinate data quality reviews to support business objectives (e.g., system data reviews, PSUSA/XEVMPD, and Annual Pharmacovigilance Fees)

    • 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

    • Develop approaches to support with data collection, transformation, mapping, and enrichment from and between documents and systems

    • Develop operational and governance models to support readiness activities for new data focused regulatory obligations (e.g., IDMP)

    Qualifications and Skills (Required):

    • Bachelor's Degree with relevant experience

    • 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)

    • 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)

    • 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

    • 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

    Qualifications and Skills (Preferred):

    • 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

    • PMP Certification or similar

    • 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

    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.

    Regulatory Affairs

    #LI-PFE

    Why you should apply for a job to Pfizer:

  • 4.1/5 in overall job satisfaction
  • 4.6/5 in supportive management
  • 78% say women are treated fairly and equally to men
  • 79% would recommend this company to other women
  • 81% say the CEO supports gender diversity
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • 23-25 Week Maternity Leave (Fully paid for birth parents)
  • Family building benefits include $35,000 fertility services + $25,000 adoption and surrogacy services
  • Pfizer is a founding member of Healthcare Businesswomen's Association Gender Parity Collaborative