CT Platform Team Lead
Pfizer Canada Inc.
Escazu, Costa Rica
hace 5 días

Primary Responsibilities

  • Efficiently manages CT Platform resourcesOrganizes and leads recruitment for the CT Platform;Monitors and manages training of CT Platform colleagues, and ensures appropriate coaching and mentoring;
  • Provides guidance to CT Platform colleagues for standardization of processes and goals;Mentors colleagues on the effective use of the corporate safety database;
  • Manages and monitors the effective rollout of new processes;Ensures timely and accurate handling of individual AE / SAE reports to meet corporate and regulatory reporting requirements for individual reports and aggregate reports;
  • Provides oversight and guidance to CT Platform colleagues on review and processing of AE / SAE reports under the scope of the CT Platform;
  • In cooperation with PSSR CoE Case Processing Head, Case Processing Cluster Team Leads, DSU CSLs and DSU RHs, manages available resources to ensure effective processing of CT Platform caseload.

  • Utilizes corporate tools to manage the CT Platform performanceConsolidates and reviews quality assessments and metrics to measure performance of the CT Platform operations;
  • where applicable defines and implements corrective and preventive actions;Takes responsibility for identifying the root causes of timeliness or quality issues associated with case processing and implementing the corrective and preventive actions when warranted.

  • Collaborate with Pfizer clinical teams, DSU CSLs, and other relevant functional representatives for clinical study, non-
  • interventional study and compassionate use AE / SAE reporting, end of study unblinding and reconciliation if needed.Acts as subject matter expert for the CT Platform;
  • Facilitate resolution of concerns and questions
  • Technical Skill Requirements

  • Knowledge of global regulations governing safety reporting of clinical study, non-interventional study, and compassionate use sourced reports;
  • Rational approach to issues and their business implications;
  • Good problem solving and decision making skills;
  • Team building and team management skills;
  • Strong interpersonal skills, with a demonstrated ability to manage people and foster teamwork;
  • Good oral and written communication and negotiation skills, with fluency in spoken and written English
  • Highly skilled in time management and change management, organizational and facilitation skills;
  • Ability to meet personal objectives while meeting departmental standards of performance;
  • Ability to perform Senior CT Platform Safety Associate tasks when required.
  • Qualifications (i.e., preferred education, experience, attributes)

  • Healthcare professional education required;
  • Bachelor degree in medicine, pharmacy, nursing or equivalent, advanced degreepreferred;
  • 1+ years of experience in people management preferred;
  • Experience in mentoring / training;
  • Minimum 3 years’ experience in pharmacovigilance and / or data management, clinical care, or clinical or scientific research required;
  • Good understanding of medical terminology. Experience and skill with medical writing has an advantage;
  • Demonstrated computer literacy, particularly in the use and management of relational databases;
  • Established knowledge of U.S. and international regulations in area of clinical trial and pharmacovigilance.
  • Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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