Job for M.Pharm, B.Pharm as Data Associate at Pfizer
Post : Centralized Data Management - Data Associate (India)
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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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