Safety Surveillance Associate

Pfizer Inc.

Makati City, Philippines

Job posting number: #7136054 (Ref:pf-4881161)

Posted: March 24, 2023

Application Deadline: Open Until Filled

Job Description

Position purpose

Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pfizer’s products and to meet regulatory requirements.

Primary Responsibilities

  • Identify and select routine cases for processing, determining appropriate prioritizationcriteria, and noting reasons for any delays.
  • Assess cases to distinguish those with particular complexities and/or specific issues, andescalate 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 appropriate case follow-up, requesting follow-up letters when appropriate.
  • 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 products within the Pfizer portfolio; 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.

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.

· 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.

Qualifications

· 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: Flexible

#LI-P

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

Medical

#LI-PFE


Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.


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More Info

Job posting number:#7136054 (Ref:pf-4881161)
Application Deadline:Open Until Filled
Employer Location:Pfizer Inc.
New York,New York
United States
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