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Leads Clinical Data Sciences activities for clinical trials, coordinating data acquisition standards, data management plans, quality risk indicators, third-party data oversight, and inspection readiness. Provides leadership and direction to data management resources, ensures data quality and timely deliverables, partners with cross-functional teams and external providers, and maintains compliance with SOPs, regulations, GCDMPs, ALCOA principles, and Trial Master File requirements.
Top Skills:
Alcoa PrinciplesClinical Data StandardsData Management PlansGcdmpTrial Master File (Tmf)
Position Purpose
Primary Responsibilities
Technical Skill Requirements
Qualifications (i.e., preferred education, experience, attributes)
Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical
- Individual filling the position are responsible for the project management of safety aggregate reports submitted to regulators that include the FDA and EMA. The incumbent will partner with various colleagues from Clinical, Regulatory, Safety, and other functional lines to produce the aggregate reports and ensure that these reports are completed in a timely manner meeting regulatory compliance.
Primary Responsibilities
- Lead report preparation from prep to submission with key stakeholders/contributors within Clinical, Regulatory, Safety, DevOps, Submissions, etc.
- Review data to ensure consistency between various contributors.
- Compile the information for reports using various electronic tools and document management system.
- Coordinate the review and approval of the report and address review comments.
- Ensure reports are completed prior to regulatory due date to meet compliance.
- Provide guidance to contributor regarding report requirements.
- Participate in projects or subject matter tasks that support the group and deliverables.
- Participate in developing and performing User Acceptance Testing (UAT) as required.
- Complete training in accordance with Pfizer's and WSR Safety information Management curriculum.
Technical Skill Requirements
- Experience in the pharmaceutical industry, clinical research, or healthcare related field.
- Experience with Microsoft Word & Excel, Adobe Acrobat, ISI Toolbox, etc.
- Experience with SharePoint technology (e.g., Microsoft InfoPath, SharePoint Designer, etc.)
- Business Objects experience is a plus.
Qualifications (i.e., preferred education, experience, attributes)
- Bachelor's Degree in life sciences, healthcare, or pharmaceutical discipline required.
- Excellent English verbal, written communication and presentation skills required.
- Must be detail-oriented.
- Strong project management and issue resolution skills required.
- Demonstrated ability to perform in a cross-functional environment.
- Knowledge of regulatory/safety regulations and guidelines desired.
Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical
Pfizer Chennai, Tamil Nadu, IND Office
Chennai, India
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