The Global Product Development (GPD) Centre supports all clinical and late-stage development of medicines. It also supports regulatory affairs across all therapeutic areas in Pfizer. GPD has three sub functions:
1.Global Site and Study Operations (GSSO) is located at Mumbai and is part of the Clinical Development and Operations (CD&O) function. CD&O comprises several subunits which work as one team to ensure a seamless convergence of clinical scientific expertise with operational excellence to deliver comprehensive solutions. This team is committed to excellence and to efficiently answering key scientific questions about Pfizer's innovative portfolio in a clinical setting. The GSSO team oversees the end-to-end operations of clinical studies conducted in India for Indian and global registration.
2. The Global Biometrics and Data Management (GBDM) function is based in Chennai and supports all clinical developments across Pfizer. GBDM delivers innovative designs and quantitative methods for assets and programs. It also ensures high quality reporting for trials and submissions. GBDM is committed to being a preferred collaborative partner to harness the power of data that supports robust evidence-based decision-making. Key activities include:
Providing statistics from proof of concept to Phase IV trials for Pfizer’s entire clinical portfolio
Programming and data management for Phase I through Phase IV of Pfizer’s entire clinical portfolio
Defining and implementing of enterprise-level vision and strategy across the biometrics and data management disciplines
Ensuring the integrity of Pfizer’s clinical trial data
Pharmaceutical Sciences (PharmSci) is specialized and focused on applying cutting-edge product design and process development capabilities, to bring best-in-class therapies to patients. PharmSci is a strategic part of Pfizer Medicinal Sciences, dedicated to parenteral drug products for our Hospital business. Our Product Development is focused on anti-infectives, oncolytics, sterile injectables, anesthesia and uniquely differentiated hospital products.
Pfizer’s patient centric approach encourages our scientists to partner with physicians and hospitals to generate innovative concepts and ideas, exploiting both market needs and synergies across therapeutic areas. Our capabilities include development of differentiated products such as device-combination products, complex/value-added formulation, controlled-release dosage forms, ready-to-use formulations, lyophilized injections and powder-fill products. Extractables and Leachables group study a wide variety of containers and closures using a high-end analytical technology.
The analytical methods (Chemical and Microbiology) determine critical quality attributes of drugs and helps ensure sterility of our manufacturing facilities and safety of our products. Pharmaceutical Sciences attracts scientists and professionals from a wide range of scientific disciplines including Formulation Scientists or Pharmacists, Analytical Scientists, Life Science specialists - Microbiologist/Biotechnologist, Chemical Engineers, Data Scientists, Program Managers and others.
Global Technology and Engineering (GT&E) pioneers manufacturing technology to supply medicines to patients across the globe by delivering value through a sense of urgency, decisiveness and innovation and thus live Pfizer’s purpose- Breakthroughs That Change Patients’ Lives.
GT&E team in India comprises of high caliber scientists with expertise in process, analytical and formulation medicinal sciences. GT&E have made great strides over the years in delivering results in small molecule, analytical and sterile injectables technologies by bringing next generation API process and analytical method development, process and analytical tech transfers. Structural and material characterization, particulate investigations, optimization and development of Lyo cycle, life cycle management, genotoxic impurities, chemistry manufacturing and control support, process safety assessments and supporting new product launch across the globe.
Based out of Chennai, the GT&E Center of Excellence (CoE) with its state of art labs, develops technologies within Pfizer to help define the future of manufacturing in delivering high quality products by bringing in cutting edge technology with focus on supply assurance. GT&E CoE partners with Pharmaceutical Sciences organization in the Small Molecule Innovative and Generic Sterile Injectables arena to help advance the portfolio apart from supporting chemical research, lyophilization cycle & analytical technology and technology transfer for manufacturing sites.
Patient safety is the foundation for everything Pfizer is doing. For more than a century, taking care of patients and their well-being has been at the core of what we do every day. Medical Excellence, Regulatory Compliance and Operational Excellence are the three pillars of drug safety.
The Worldwide Safety team is responsible for conducting all strategic and operational aspects of pharmacovigilance, from early development through submission and onto post approval. Colleagues from more than 50 countries work together to collect, understand, assess and prevent adverse effects or any other possible drug-related problems and to contribute to a robust understanding of benefit/risk profiles across the portfolio.
The Worldwide Safety functional lines in PHIPL work together to collect, analyze, and draw conclusions from safety events to inform the understanding of the safe and effective use of our medicines by patients.