PFIZER
Centralized Data Management - Data Associate (India)
Position
Purpose
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 whilst
adhering to all policies, practices and procedures. Timeliness/ 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 products 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.
Primary
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 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
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)
Qualifications
(i.e., preferred education, experience, attributes)
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
Pfizer
is an equal opportunity employer and complies with all applicable equal
employment opportunity legislation in each jurisdiction in which it operates.
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