Safety Surveillance Associate
hace 6 días
Use Your Power for PurposeOur mission is straightforward: empower healthcare decisions regarding the safe and appropriate use of medicines for patients.
Whether you are developing the framework to ensure our evidence is scientifically robust, providing unbiased and medically essential expertise, or exploring ways to bridge data gaps, your role is vital.
By ensuring our evidence is sound and offering necessary medical insights, we strive to improve patient care and treatment efficacy.What You Will AchievePosition PurposeReview, preparation, and completion of reports of adverse drug experiences, to determine thesafety profile of Pfizer's products and to meet regulatory requirements.In this role, you will:Identify and select routine cases for processing, determining appropriate prioritization criteria, and noting reasons for any delays.Assess cases to distinguish those with particular complexities and/or specific issues and escalate appropriately.Review, rank, verify, process and document: event terms; case classifications (validity, seriousness, expectedness/listedness/labeledness); special scenarios; product complaint information; reportability with due date; and accuracy and consistency.
Based on assessment of cases, process accordingly.Review case criteria to determine the appropriate workflow for case processing.Write and edit the case narrative.Generate reports, ensuring adherence to regulatory compliance timelines.Determine appropriate case follow-up, requesting follow-up letters when appropriate.Liaise with key partners, including Pfizer Country Organizations, Clinical Development, License Partners, and other stakeholders regarding safety data collection and data reconciliation.Develop and maintain expertise and knowledge of all products within the Pfizer portfolio; applicable corporate and global regulations, guidelines, Standard Operating Procedures and writing practices; data entry conventions; and search functions in the safety database.Consistently apply regulatory requirements and Pfizer policies.
Technical Skill RequirementsExperience in pharmacovigilance, in clinical care, or in clinical or scientific research is an advantage but not a requirement.Demonstrated computer literacy, particularly in the use and management of relational databases.Ability to achieve personal objectives while meeting departmental standards of performance.Ability to work under supervision in a matrix organization.Excellent oral and written communication skills.Fluency in spoken and written English; knowledge of additional language(s) an advantage.Experience and skill with medical writing an advantage.Must-HaveBachelor's degree in a science-related field, pharmacy, nursing, or equivalent; healthcare professional qualification preferred.Health Care Professional (HCP), (nurse, pharmacist, etc.
)Ability, with supervision, to solve routine problems and to surface issues constructively.Ability to make basic decisions with an understanding of the consequences.Nice-to-HaveExperience in pharmacovigilance, in clinical care, or in clinical or scientific research.Knowledge of additional language(s) an advantage.Experience and skill with medical writing an advantage.
Work Location Assignment: On PremiseEEO (Equal Employment Opportunity) & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.Medical#LI-PFE
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