Safety Surveillance Associate

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.

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