Manage end-to-end preparation and submission of safety aggregate reports for regulators (FDA, EMA). Coordinate cross-functional contributors, compile and review data, manage approvals and review comments, ensure regulatory deadlines and compliance, support UAT, and complete required safety information management training.
Position Purpose
Primary Responsibilities
Technical Skill Requirements
Experience with:
Business Objects/Business Intelligence experience is a plus.
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.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
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 Safety, Clinical, Regulatory 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 with:
- Microsoft Products, (e.g., Word, PowerPoint, Excel, Outlook, Teams)
- SharePoint technology
- PDF software (e.g., Adobe)
Business Objects/Business Intelligence experience is a plus.
Qualifications (i.e., preferred education, experience, attributes)
- Bachelor's Degree in life sciences, healthcare, or pharmaceutical discipline required.
- Experience in the pharmaceutical industry, clinical research, or healthcare related field is preferred.
- Excellent English verbal, written communication and presentation skills required.
- Must be detailed 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.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Medical
Pfizer Chennai, Tamil Nadu, IND Office
Chennai, India
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