PfizerSafety Aggregate Report Coordinator Associate
Pfizer is hiring a Safety Aggregate Report Coordinator Associate for a remote role open to applicants in Poland. It pays PLN 101k a year and Level rates it ; you can apply on Pfizer.
Level's read on this job
- Level rates this role Little AI ●○○○: aI is not part of the work.
- This is listed as a remote role.
- The posting mentions Microsoft Word, Microsoft PowerPoint and Microsoft Excel among its tools and skills.
- Pfizer has 566 other open roles on Level.
- Posted in the last few days.
AI in this role
Coordinate the project management and preparation of safety aggregate reports for regulatory submission to the FDA and EMA.
Position Purpose
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 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.
Minimal annual gross base salary: 100.500 PLN
Annual Bonus: 10%
Benefits: Medicover, MultiSport, UNIQUA, PPE at Goldman Sachs and other, as per Pfizer Pay Policy
Work Location Assignment: Hybrid
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Disability Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!
Pursuant to Article 24(6) of the Act of June 24, 2024 on the protection of whistleblowers, Pfizer Polska Sp. z o.o. and Pfizer Trading Polska Sp. z o.o. declare that they have adopted a joint internal reporting procedure, which, in accordance with the provisions of the aforementioned Act, is also available to persons applying for employment on the basis of an employment relationship or other legal relationship constituting the basis for providing work or services or performing functions. The content of the procedure is made available upon request sent to the contact person or to the email address sygnalisci-px@pfizer.com.
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
How we rate this
Safety Aggregate Report Coordinator Associate at Pfizer rates 0 out of 100 for how much of the daily work is AI. That makes it Little AI (AI Level 1 of 4). The level is about AI in the job, not seniority.
Little AI. AI is not part of the work.
- ●●●● Builds AI80 to 100
- ●●●○ Works on AI60 to 79
- ●●○○ Uses AI40 to 59
- ●○○○ Little AI0 to 39
Levels come from how often the tools, models and workflows of the role are named in the posting itself. Read the description and count the AI tools, models and workflows it names.
Prepare for this job
Built from this posting and from similar jobs on Level.
Skills and AI tools this role asks for
Questions you could be asked
- Tell me about a project where project management was part of your work. What did you do?
- Tell me about a project where regulatory compliance was part of your work. What did you do?
- Tell me about a project where documentation was part of your work. What did you do?
- Tell me about a project where cross functional leadership was part of your work. What did you do?
- Tell me about a project where user acceptance testing was part of your work. What did you do?
Adapt your resume
- List these exact terms on your resume: Project Management, Regulatory Compliance, Documentation, Cross Functional Leadership, and User Acceptance Testing. An applicant tracking system matches the wording, not the idea.
- Attach one line of real, concrete experience to at least one of them. A tool named with nothing behind it rarely survives a human read.
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