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.
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.
About this role This position is part of the local Drug Safety team and an entry level role which reports to the Safety Team Lead.
Primary Responsibilities Carry out case intake activities prioritisation activitiesReview, rank, verify, process and document case-related information: event terms; validity, seriousness, special scenarios; timelines; accuracy and consistency.Review case criteria to determine appropriate workflow for case processingAssess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriatelyDetermine and perform appropriate case follow-up, including generation of follow-up requestsReview processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenariosLiaise with key partners, locally, and other stakeholders regarding safety data collection and data reconciliationDevelop and maintain expertise and knowledge for applicable corporate and global regulations, for guidelines, Standard Operating Procedures, for data entry conventions, and for search functions in the safety databaseDetermine reportability of scheduled reports, ensuring adherence to regulatory requirementsConsistently apply regulatory requirements and Pfizer policiesParticipate, as appropriate, in local, internal and external safety activitiesTechnical Skill Requirements Experience in pharmacovigilance and/or data management preferred but not requiredExperience and skill with medical writing an advantageDemonstrated computer literacyExperience in the use and management of relational databases preferredQualifications (i.e., preferred education, experience, attributes) Health Care Professional or equivalent experience preferredAbility, with supervision, to solve routine problems and to surface issues constructivelyAbility to make basic decisions with an understanding of the consequencesAbility to achieve personal objectives while meeting departmental standards of performanceAbility to work under supervision in a matrix organizationFluency in spoken and written English#J-18808-Ljbffr
