Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.
Post : Centralized Data Management - Data Associate (India)
Job Description
• 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 in 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
• Identifies issues and provides 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
• Adhering 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
Candidate Profile
• Academic Degree: Professional in Pharmaceutical Chemistry
• Regulatory knowledge and experience (at least 1-2 years)
• Demonstrated ability to work in a highly regulated environment
• Project Management Experience desirable
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Technical Skill Requirements
• 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)
Additional Information:
Experience: 1-2 years
Location: Chennai
Education: B.Pharm / M.Pharm
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: Centralized Data Management
Job ID: 4686007
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