Similar Jobs at Pfizer
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Authors, reviews, and maintains clinical trial Basic Results disclosures for ClinicalTrials.gov, CTIS, and EudraCT. Translates clinical data and statistical outputs into compliant results records, coordinates with clinical, statistical, legal, medical writing, and study teams, addresses quality and regulator comments, maintains audit-ready documentation, and supports disclosure process improvements, training, and best practices.
Top Skills:
42 Cfr Part 11Clinicaltrials.GovCtisEu Ctd 536/2014Eu Ctr 536/2014EudractFdaaa 801Xogene Prime
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Manage and improve Pfizer’s enterprise PKI and certificate lifecycle services. Responsibilities include designing, deploying, integrating, testing, upgrading, and supporting Microsoft Certificate Authority environments, certificate automation, HSMs, and related security services. The role provides technical leadership, operational oversight, incident and problem management, stakeholder coordination, mentoring, and 24x7 support for critical PKI services.
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C++Certificate Lifecycle Management (Clm)Digital SignaturesHardware Security Modules (Hsm)Identity And Access Management (Iam)ItilJavaMicrosoft Certificate AuthorityPublic Key Infrastructure (Pki)PythonRegistration AuthorityRemote Key ManagementSecurity Worlds
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Manages Pfizer’s clinical trial data sharing and disclosure operations, including study registration, results posting, external data requests, compliance, quality reviews, metrics, and policy support. Partners with clinical, medical, legal, statistics, data management, communications, and external stakeholders to deliver disclosure commitments across ClinicalTrials.gov, EudraCT, and Pfizer.com. Leads project tracking, vendor coordination, performance analysis, risk resolution, and cross-functional execution in a global pharmaceutical environment.
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CdiscClinicaltrials.GovElectronic Medical Record SystemsEudractFhirHl7ExcelMS OfficeMicrosoft Powerpoint
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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