CT Platform Safety Associate
myGwork - LGBTQ+ Business Community
Date: 2 weeks ago
City: Makati City
Contract type: Full time
This job is with Pfizer, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.
Position Purpose
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
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical
Position Purpose
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
- Carry out case book-in, data entry and processing activities.
- Assess cases to distinguish those with particular complexities and/or specific issues and escalate appropriately.
- Identify and select cases for data entry, determining appropriate prioritization criteria and noting reasons for any delays
- Review, rank, process and document case-related information: event terms; case classifications (validity, seriousness, expectedness/listedness/labeledness), special scenarios, product complaint informtion, reportability with due date; and accuracy and consistency. Based on case assessment, 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.
- 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.
- 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.
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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