Why Patients Need You
Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.
What You Will Achieve
You will be relied on by the company to monitor its drug, biologics and medical devices surveillance program. This will include intake, evaluation and processing of the adverse reports received. You will support the clinical trial as well as the post marketing activities.
Want more jobs like this?
Get Business Operations jobs in Warsaw, Poland delivered to your inbox every week.
As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.
It is your dedication and hard work that will make it possible for Pfizer's customers and patients to receive the medicines they need, when they need them.
Key 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.
How You Will Achieve It
- Contribute to completion of project milestones and organize own work to meet project task deadlines.
- Provide project teams with expertise on regulatory requirements and corporate policies governing documents for regulatory submission.
- Support Worldwide Strategy and Regulatory teams by providing analyses of post-marketing safety data, reviews of the medical literature, and similar related activities.
- Review case criteria to determine the appropriate workflow for case processing.
Qualifications
- 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.
- Bachelor's Degree in life sciences, healthcare, or pharmaceutical discipline required.
- 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.
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!
Medical
#LI-PFE