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Organizational Relationship(s) including to whom the position reports (JD Job
Title):

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Reports to CT Platform Team Lead



Position Purpose

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Review, preparation, and completion of clinical study and compassionate
sourced adverse event (AE)/serious adverse event (SAE) reports, to determine
the safety profile of Pfizer’s products and to meet regulatory requirements.



Primary Responsibilities

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Carry out case book-in, data entry and processing activities.

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Assess cases to distinguish those with particular complexities and/or specific
issues, and escalate appropriately.

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Identify and select cases for data entry, determining appropriate
prioritization criteria, and noting reasons for any delays

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Review, rank, process and document case-related information: event terms; case
classifications (validity, seriousness, expectedness/listedness/labeledness),
special scenarios, product complaint information, reportability with due date;
and accuracy and consistency. Based on case assessment, forward the case to the
appropriate workflow.

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Write and edit the case narrative.

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

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

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

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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.

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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

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Experience in pharmacovigilance, in clinical care, or in clinical or
scientific research is an advantage but not a requirement.

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Demonstrated computer literacy, particularly in the use and management of
relational databases.

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Excellent oral and written communication skills.

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



Qualifications (i.e., preferred education, experience, attributes)

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

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

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

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Ability to achieve personal objectives while meeting departmental standards of
performance

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Ability to work under supervision in a matrix organization.


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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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