9 days old

Clinical Trial Hub Safety Associate

Pfizer
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**Why Patients Need You**



Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.



**What You Will Achieve**



You will be relied on by the company to monitor its drug, biologics and medical devices surveillance program. This will include intake, evaluation and processing of the adverse reports received. You will support the clinical trial as well as the post marketing activities.



As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing important deliverables on time. Your innovative use of communication tools and techniques will make it easy to manage difficult issues and help in establishing consensus between teams.



It is your dedication and hard work that will make it possible for Pfizer's customers and patients to receive the medicines they need, when they need them.



**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 information, 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.



**Qualifications**

**Must-Have**



+ Bachelor's Degree in a science-related field, pharmacy, nursing, or equivalent; healthcare professional qualification preferred.

+ Demonstrated organizational/project management skills

+ Solid knowledge of global regulations and guidelines for drug development

+ Demonstrated analytical and statistical skill.

+ Ability to make decisions independently and resolve issues appropriately

+ Ability to achieve personal objectives while meeting departmental standards of performance

+ Ability to work under supervision in a matrix organization.

+ Strong skills in productivity, organizational and time management in order to meet strict regulatory compliance goals

+ Fluent in spoken and written English



**Nice-to-Have**



+ Master's degree

+ Knowledge of additional language

+ Relevant pharmaceutical industry experience

+ Familiarity with management of performance metrics

+ Ability to make decisions independently in both routine case processing and unique and/or complex situations, and to resolve issues appropriately to achieve a desired result or impact



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
Posted: 2021-06-11 Expires: 2021-07-12
Sponsored by:
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Clinical Trial Hub Safety Associate

Pfizer
Escazu

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