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.
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.
