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Pfizer, S.A. de C.V

Associate Director, Clinician, Medical Monitor - Vaccines (MD required)

Pfizer, S.A. de C.V, Pearl River, New York, United States, 10965


We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.ROLE RESPONSIBILITIESAccountable for safety across the studyProvide study team with medical advice for all medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site and patient level.Ensures development of and adherence to the Safety Surveillance Review Plan (SSRP). Performs and documents regular review of individual subject safety data, and performs review of cumulative safety data with the safety risk lead.Monitor study safety issues and provide input to serious adverse events (SAEs) reports.Participates in the Safety Review Team to evaluate medical benefits/risks to support targeted clinical indications.Communicates safety information to sites across the study and provides responses to questions on safety.Protocol design and strategyContributes towards the medical input during protocol development and updates to the clinical development plan.Work closely with other medical monitors to ensure that documents meet regulatory requirements and company policy.Provides medical input into country feasibility.Support study teamProvides clinical input to protocol/study team for monitoring guidelines, statistics analysis plans, and clinical review forms.Contributes to contract research organization/vendor selection to ensure study is conducted consistent with protocol requirements.Works with study team to ensure high quality of data.Provides protocol specific training to study team, investigators, and clinical research associates.Interacts with healthcare professionals at sites during the conduct of the study.Interact with regulatory authorities, key opinion leaders, and principal investigatorsMay support Clinical Regulatory Authority interactions accountable for providing responses.Liaise with Key Opinion Leaders and Principal Investigators in countries to build a network for new trials.BASIC QUALIFICATIONSMedical degree (M.D./D.O. or equivalent).Licensed by a health authority to prescribe medicines for at least one year.0-4 years' work experience.Possesses the ability to critically evaluate medical/scientific information.Excellent written and oral communication.Capacity to adapt to a fast pace and changing environment.PREFERRED QUALIFICATIONSDocumented work experience/knowledge of statistics.Training and experience in infectious diseases and/or infection control.Experience with investigational clinical trials is preferred.Work Location Assignment: On Premise.The annual base salary for this position ranges from $173,300.00 to $288,800.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 22.5% of the base salary.Relocation assistance may be available based on business needs and/or eligibility.EEO & Employment EligibilityPfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants.

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