Sun. May 26th, 2024

About Us

Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.

Executive

Qualifications

Must-Have

  • Bachelor’s Degree
  • Demonstrated experience
  • Relevant experience in electronic submissions build within the Pharmaceutical Industry
  • Demonstrated coordination of activities in a highly regulated environment
  • Demonstrated experience working in a challenging customer service environment
  • Knowledge of the drug development process
  • In-depth understanding of systems and electronic technologies used to support submission and planning activities, as well as demonstrated experiences in process development and new technology implementation
  • Good knowledge of English, spoken and written

Nice-to-Have

  • Experience in project management

How You Will Achieve It

  • Contribute to the completion of project milestones and organize own work to meet project task deadlines.
  • Execute, through use of standards and tools, designated operational tasks or through the applicable Pfizer country office, conforming to regulatory submission milestones and applicable regulatory obligations.
  • Help interpret regulatory guidelines to produce business requirements and ensure that those requirements are implemented where appropriate at local level.
  • Promote quality as a best practice based on knowledge of regulatory requirements, departmental guidelines, and Quality Control (QC) experience.
  • Support the regulatory activities associated with allocated new food supplements in development.
  • Compile, verify accuracy, and sort regulatory license information for products identified for withdrawal.
  • Contribute to effective forecasting and management of project specific resources utilizing flexible resourcing, and global load sharing as normal business practice.
  • Communicate with internal team members about execution and strategy as needed
  • Actively pursue training in technical and personal skills relevant to the Certificate Signing Request Coordinator role.
  • Act as a subject matter expert on global regulatory requirements in the cross functional team.

Senior Associate, Central Monitor

BASIC QUALIFICATIONS:

  • Bachelor’s degree or above of equivalent experience in a scientific or business related discipline required.
  • 3 – 5 years working experience in the clinical development fields.
  • Working knowledge of clinical development process, understanding concepts of Phase I-IV and principles of study design
  • Previous experience within a data management role, understanding key processes and principles associated with role including CRF design, database set-up, edit check specification, DMPs and data cleaning activities
  • Knowledge of clinical trial database and its applications
  • Knowledge of Windows Environment and its applications (Word, Excel, PowerPoint, Project, etc.)
  • Experience in Oracle, PL/SQL, SAS, Java, relational database design and database programming skills.

Technical Skill Requirements:

  • Technical expertise and business experience in supporting clinical trials database development, data management, site monitoring, etc.
  • Thorough understanding of the processes associated with clinical study management, data management, and regulatory operations.
  • Project management skills and technical capabilities as well as effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
  • Works independently, receives instruction primarily on unusual situations
  • Ability to organize tasks, time and priorities; ability to multi-task
  • Ability to communicate effectively and appropriately with internal & external stakeholders, locally and globally
  • Strong understanding of the state-of-the-art technologies to evaluate and leverage them into improved business processes for worldwide deployment and adoption.

ROLE RESPONSIBILITIES

General:

  • Implement global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality processes to meet quality, timelines and deliverables.
  • Provide technical expertise to set up and test study level Risk-based Monitoring system
  • Review study level system outputs to process for the signal and action management
  • Plan and execute communication plans & methods to ensure customer satisfaction and enable improvements to be implemented during the course of a study.
  • Able to resolve conflicts, influence and communicate with key stakeholders and customers.
  • Implement quality oversight/control steps implemented in the central monitor activities.

System setup Functions:

  • Review protocols to ensure the set-up, review and reporting requirements can be met and are standardized.
  • Provide technical oversight, guidance and coordination for all the central monitor activities.
  • Set up and test RBM system at study level to ensure system quality.
  • Define key risk indicators (KRIs) in study system, and ensure consistency between the standard level and the study level.
  • Set up dictionary for data quality assessment  DQA in study system
  • Ensure RBM system align with the protocol and adhere to ICH GCP, SOPs, corporate standards and regulatory requirements.

Data review Functions:

  • Work with Study Team to define the issue resolution for the reviewing findings as signal and action.
  • Develop, implement and maintain Quality Control related documentations for RBM related activities to ensure data completeness and accuracy.
  • Perform central monitoring activities including review system outputs, propose suggestion for signal and action management, and follow up with study team for the action resolution.
  • Work with Clinical Data Scientist to ensure all signal and actions are properly mitigated and RBM systems properly released.
  • Ensure lessons learnt during the course of the study are documented and shared with other central monitors/ study teams to facilitate cross-study learning.

By Sivamin

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