Use Your Power for Purpose
At Pfizer, our Worldwide Medical and Safety colleagues are pivotal in bridging evidence-based medical decision support with stakeholders to enhance health and treatment outcomes. Whether you are developing frameworks to ensure our evidence is scientifically robust, offering unbiased and medically essential expertise, or exploring ways to address data gaps, our mission remains clear: to empower healthcare decisions regarding the safe and appropriate use of medicines for patients.
What You Will Achieve
In this role, you will:
Monitor the company's drug, biologics, and medical devices surveillance program.Intake, evaluate, and process adverse reports for both clinical trials and post-marketing activities.Make decisions within limited options to resolve problems, under the supervisor's direction.Work in a structured environment, following established procedures.Ensure work is regularly reviewed for technical judgment, completeness, and accuracy.Provide expertise on regulatory requirements and corporate policies for regulatory submissions to project teams.Support Worldwide Strategy and Regulatory teams by analyzing post-marketing safety data, reviewing medical literature, and related activities.Determine the appropriate workflow for case processing by reviewing case criteria.Responsibilities
• 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 and perform appropriate case follow-up, generating and requesting follow-up letters.
• 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 assigned products within a therapeutic
area; 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.
Qualifications
• 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.
• 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.
• Ability, with supervision, to solve routine problems and to surface issues constructively.
• Ability to make basic decisions with an understanding of the consequences.
Bachelor's degree in a science-related field, pharmacy, nursing, or equivalent; healthcare
professional qualification preferred.
Responsibilities
• 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 and perform appropriate case follow-up, generating and requesting follow-up letters.
• 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 assigned products within a therapeutic
area; 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.
Qualifications
• 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.
• 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.
• Ability, with supervision, to solve routine problems and to surface issues constructively.
• Ability to make basic decisions with an understanding of the consequences.
Bachelor's degree in a science-related field, pharmacy, nursing, or equivalent; healthcare
professional qualification preferred.
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.
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