Drug Safety Surveillance
5 dni temu
Pfizer is excited to present an opening for an enthusiastic, talented, dynamic, international mind-set and motivated Drug Safety Surveillance / Pharmacovigillance Associate within the Worldwide Safety department – Site of Poland-Warsaw.
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.
The Safety Surveillance Associate is responsible for the review, preparation, and completion of individual case safety reports of adverse drug experiences originating from any source (either investigational or post-marketing) in the global safety database, to determine the safety profile of Pfizer’s products and meet regulatory requirements, empowering healthcare decisions regarding the safe and appropriate use of medicines for patients.
Key Experience Offer of this Role
The Drug Safety Surveillance / Pharmacovigillance Associate is an integral member of a structured team and will report to the Case Processing Team Lead, based in Milan (Italy).
You will have the opportunity to:
be a team member who is relied on to have a solid understanding of Safety procedures, techniques, tools and materials.
develop and maintain expertise and knowledge of all products within the Pfizer portfolio.
liaise with key partners, including Pfizer Country Organizations, Clinical Development, and other stakeholders regarding safety data collection.
collaborate with quality lines and relevant project team subject matter experts, ensuring the accuracy and quality of information presented in assigned cases.
identify potential areas for process improvements and possible solutions and communicate these to line management.
This position requires a good knowledge of the proactive, pragmatic, flexible person with good communication & presentation skills, used to working in a team or with a proven propensity to, able to adapt to working procedures and processes (very structured and with strict and timelines) and new scenarios, positive approach to the changes (business needs), always ready to new challenges, quick learner, open minded, available in acquiring increasing and more complex responsibilities in time. And finally so much curiosity and desire to learn.
We are happy to offer you:
Dynamic environment, group of junior/senior colleagues to interact with
In-depth training/mentoring process
Growth potential
Primary Responsibility
You will follow standard procedures to support and complete tasks, some of which may vary in scope, sequence, complexity and timing, requiring flexibility and multitasking skills but you will also contribute to the team’s success by sharing your enthusiasm, collaboration and your previously acquired knowledge.
Your main responsibilities will focus on:
Identifying, assessing and processing cases, including writing and editing of case narrative, to allow the generation of reports and ensure adherence to regulatory compliance timelines.
Selecting routine cases for processing, determining the appropriate prioritization criteria, and noting reasons for any delays.
Reviewing, ranking, processing and documenting of event terms, case classifications (validity, seriousness, labeling), special scenarios, product complaint information, reportability with due date, accuracy and consistency, applying appropriate process of cases based on assessment.
Assessing cases to distinguish those with complexities and/or specific issues requiring proper escalation.
Determination of appropriate case follow-up, requesting follow-up letters when appropriate.
Applying corporate and global regulations, guidelines, Standard Operating Procedures and writing practices, data entry conventions and search functions in the safety database.
What You Offer
Basic Qualifications
Bachelor’s degree in a science-related field, Pharmacy, or equivalent (healthcare professional qualification preferred).
Experience in pharmacovigilance, regulatory, or in clinical or scientific research is an advantage but not a requirement.
Due to the international environment, fluent English in comprehension, reading and speaking skills (C1 or higher), and German (B2 or higher) is a requirement. In addition, also fluent Portuguese is an advantage,
Ability to manage data inaSafety database (Argus preferred) is an advantage but not a requirement.
Microsoft Office competent user (mainly Word, PowerPoint, Excel).
Furthermore, you are a young minded, practical person with hands-on mentality, good planning skills with orientation to project, compliance and deadlines, consistency and pro-active approach, effective process analytical skills. Accustomed to working under pressure due to business needs, when required.
You feel comfortable to make basic decisions with an understanding of the consequences. You have good interpersonal skills to work with multi-cultural colleagues and good motivational skills (results driven). High sense of duty.
You will be required to be at the office in Warsaw.
Preferred Qualifications
Significant knowledge in the pharmacovigilance process and safety procedures, competent and proficient in case processing.
Master in Pharmacovigilance or Pharmacovigilance-related Trainings.
Ability to work well with all levels and roles in cross-functional, global teams.
Abroad experiences (e.g. Erasmus experience).
Able to multi-task.
Mentorship Experience.
Knowledge in combo/medical devices process.
Ability to work independently to accomplish team goals with minimal supervision.
Experience in using safety related websites.
Adherence to Pfizer Values: Courage, Excellence, Equity and Joy.
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.
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