Temporary Position
Safety Data Management Specialist
Location: Costa Rica.
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
Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
Provide oversight, team mentoring on case handling aspects, data extraction and analyses and conduct follow-up activities.
Act as subject matter expert and liaise with key partners regarding safety data collection and data reconciliation.
Review, analyze, prepare, and complete safety-related reports within scope to determine the safety profile of Pfizer's products and to meet regulatory requirements.
Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios.
Manage, where applicable, safety resources in the local team.
Provide specific pharmacovigilance or product knowledge and experience, as required by the business, and mentor colleagues accordingly.
Develop and maintain advanced knowledge of all products within the Pfizer portfolio.
Develop and maintain expertise of all assigned products, of applicable corporate policies.
Design and oversee the tracking of applicable safety metrics.
Manage project and process management meeting established deadlines.
And search functions in the safety database and data mart.
Qualifications
Bachelor's Degree inhealth sciences
3+ years' experience
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
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
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
#LI-PFE
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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