CT Platform Safety Associate

essment, forward the case to the appropriate workflow.

• Write and edit the case narrative.

• Review processed cases to verify accuracy, consistency, and compliance with process requirements, and review case data for special scenarios.

• Consistently apply regulatory requirements and Pfizer policies to determine reportability of scheduled reports, generate reports, and ensure adherence to regulatory compliance timelines.

• Determine and perform appropriate case follow-up, including generation of follow-up request letters when appropriate.

• Liaise with key partners, including Global Pharmacovigilance Organization, Pfizer Safety Surveillance and Reporting Centers of Excellence, Clinical Development, License Partners, and other stakeholders regarding clinical study and compassionate use sourced

• AE/SAE collection, data reconciliation, and AE/SAE distribution/submission.

• Participate, as appropriate, in internal and external safety activities.

• Develop and maintain expertise and knowledge of all products within the Pfizer portfolio, applicable corporate and global regulations, guidelines, Standard Operating Procedures and written practices, data entry conventions, and search functions in the safety database.

Technical Skill Requirements

• Experience 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.

• Excellent oral and written communication skills.

• Fluency in spoken and written English; knowledge of additional language(s) an advantage.

Qualifications

• Bachelor's degree in a science-related field, pharmacy, nursing, or equivalent; healthcare professional qualification preferred

• Ability, with supervision, to solve routine problems and to surface issues constructively.

• Ability to make basic decisions with an understanding of the consequences.

• Ability to achieve personal objectives while meeting departmental standards of performance

• Ability to work under supervision in a matrix organization.

Work Location Assignment: Hybrid

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Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Medical

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