Data Compliance Specialist II

1 day ago

Chennai, Tamil Nadu, India Pfizer Full time

Join Pfizer's Team and Shape the Future of Medicine


We're looking for a dedicated Data Compliance Specialist II to help us bring medicines to the world faster while maintaining excellence and integrity.


About the Role


This is a multifaceted role that will offer you a number of opportunities to enhance your skills in regulatory compliance, data management, and teamwork. As a key member of our Regulatory Affairs team, you will be responsible for guiding Pfizer by interpreting federal, state, and international regulations as they apply to products, processes, practices, and procedures.


You will find yourself investigating and resolving compliance problems from within Pfizer and outside, keeping employees aware and knowledgeable about compliance policies by designing various programs, conducting audits, and evaluating current policies, procedures, and documentation.


Key Responsibilities



  • Contribute to the completion of project milestones and organize own work to meet project task deadlines.
  • Work in compliance and ensure delivery on regulatory benchmarks.
  • Collaborate across the organization with stakeholders to deliver efficiencies in regulatory submissions and processes.
  • Act as a regulatory data subject matter expert in regions supported and escalate any potential compliance issues to management.
  • Support audit as part of regulatory data and system scope.
  • Update the appropriate regulatory requirements systems and database in a timely manner when changes occur in market regulations.
  • Perform monthly compliance report review and complete remediation activities in close partnership with Regulatory strategist teams.
  • Review audit reports from the systems and resolve errors to ensure integrity of data.
  • Coordinate labeling updates for products to ensure compliance with Pfizer labeling policy and local Board of Health (BoH) regulations.
  • Prepare and/or coordinate dossier preparation, guaranteeing quality dossiers, fulfilling country regulations, and Pfizer standards in conjunction with regional teams.
  • Maintain systems and databases per internal Standard Operating Procedures (SOPs) and policies and adhere to Pfizer compliance standards.
  • Review, analyze, coordinate, and provide feedback to Head of Regulatory Affairs in matters relating to new product submissions and post-approval maintenance of products as required.

Requirements


To succeed in this role, you will need:



  • Bachelor's Degree
  • Demonstrated experience in regulatory compliance and data management
  • Proven ability to consistently deliver to time, cost, and quality standards
  • Operational knowledge of hardware and software tools required for the job
  • Excellent organizational skills and attention to detail
  • Knowledge of documentation practices
  • Fluent in English, verbal and written

Benefits and Compensation


Pfizer offers a competitive salary range of $80,000 - $120,000 per year, depending on qualifications and location. Our comprehensive benefits package includes health insurance, retirement savings, and paid time off.


How to Apply


If you are a motivated and detail-oriented professional looking to make a difference in the healthcare industry, please submit your application today. We look forward to reviewing your qualifications.

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