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  • Posted: Mar 23, 2021
    Deadline: Not specified
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    Pfizer South Africa’s vision of "living our full potential in striving for a healthier Southern Africa" forms part of Pfizer’s ethos whereby every Southern African should have access to quality healthcare. At Pfizer South Africa we are dedicated to the improvement of human life and the battle against disease & disability. We have...
    Read more about this company

     

    Safety Data Management Specialist (Contract position)

    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.

    How You Will Achieve It

    • Carry out case processing activities
    • Review, rank, verify, process and document case-related information: event terms; validity, seriousness, special scenarios; timelines; accuracy and consistency.  Process cases based on these assessments
    • Review case criteria to determine appropriate workflow for case processing
    • Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately
    • Write and edit case narrative
    • Determine and perform appropriate case follow-up, including generation of follow-up requests
    • Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios
    • Liaise with key partners, locally , and other stakeholders regarding safety data collection and data reconciliation
    • Develop and maintain expertise and knowledge for applicable corporate and global regulations, for guidelines, Standard Operating Procedures, for data entry conventions, and for search functions in the safety database
    • Determine reportability of scheduled reports , ensuring adherence to regulatory requirements
    • Consistently apply regulatory requirements and Pfizer policies
    • Participate, as appropriate, in local, internal and external safety activities

    Qualifications

    Must-Have

    • Life Science Degree preferred; 12 months pharmacovigilance/drug safety experience 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
    • Fluency in spoken and written English

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

    Method of Application

    Interested and qualified? Go to Pfizer on pfizer.wd1.myworkdayjobs.com to apply

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