Safety Surveillance Associate

Drug Safety Surveillance / Pharmacovigilance Associate with English and German/French

Pfizer is excited to present an opening for an enthusiastic, talented, dynamic, international mind-set and motivated Drug Safety Surveillance / Pharmacovigilance 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 /PharmacovigilanceAssociate 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 (B2 or higher), and German or French (B2 or higher) is a requirement.
• Ability to manage data in a Safety 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.

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.

Since it is a hybrid role, you will be required to be at the office in Warsaw for 50% of your working time.

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.