Cdm Data Associate

hace 2 semanas

Xico, México Pfizer A tiempo completo

Job Summary

This role will work within a team whose main focus will be to interpret the regulatory data received across different geographies, functions, divisions, and ensuring key activities and regulatory systems updates are completed while adhering to all policies, practices, and procedures. Timeliness and accuracy in the data entry and removal of workload associated with data entry from Regulatory Strategy teams will be key performance indicators for this role. These activities ensure data integrity to enable the organization to have visibility across all functions within a product's lifecycle. It is essential that all systems are clearly and accurately updated within the timelines specified in the Standard Operating Procedures (SOP) or business process documentation to ensure regulatory compliance.

Key Responsibilities

  • Review and interpret the data provided by the PCO to establish the system/tools required to be populated in line with current standard operating procedures or business process documentation, including systems and SOPs associated with the regulatory data scope.
  • Perform data entry and quality control tasks associated with all global regulatory systems impacted, including systems associated with the regulatory data scope.
  • Review audit reports from the systems and resolve errors to ensure integrity of data.
  • Identify issues and provide input into solutions.
  • Accountable for remediation efforts associated with their scope as part of SCC global rollout.
  • Perform monthly PEARL compliance report review and complete remediation activities in close partnership with Regulatory strategist teams.
  • Adhere to quality control procedures and standards related to the systems or tools ensuring Regulatory Compliance.
  • Support global/local team members with data management workload when necessary to provide flexible support for the portfolio.
  • Adhere to Pfizer compliance standards.
  • Act as Regulatory Data SME in regions supported.
  • Produce country/regional reports as required.
  • Support audit as part of regulatory data/system scope.
  • Contribute to the completion of moderately complex projects as needed.

Qualifications/Skills

  • Computer literacy in MS Word/Outlook/Excel/Adobe Acrobat.
  • Proven technical aptitude and ability to quickly learn and use new software, regulations, and quality standards.
  • Functional and technical knowledge and skills to do the job at a high level of accomplishment - Proven technical aptitude.
  • Quick learner with ability to multi-task.
  • Ability to work with accuracy and attention to detail.
  • Ability to work with autonomy and/or part of a team in a busy environment.
  • Demonstrated ability to work in a highly regulated environment.
  • Quality focus.
  • Customer orientation.
  • Analysis and solution of problems.
  • Effective communication.
  • English intermediate to advance (written and spoken).
  • Proven ability to coach and mentor others.
  • Proven ability to oversee and QC others' work.
  • Ability to effectively communicate with Regulatory professionals in other countries.
  • Academic Degree: Professional in Pharmaceutical Chemistry or equivalent.
  • Regulatory knowledge and experience (at least 4-5 years).
  • Demonstrated ability to work in a highly regulated environment.
  • Project Management Experience.

About Pfizer

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

EEO (Equal Employment Opportunity) & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.

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