Position Purpose

• Manage resources of the CT Platform;
• Coordinate with Drug Safety Unit (DSU) Country Safety Leads (CSLs), DSU Regional Heads (DRH), PSSR Center of Excellence (CoE) Case Processing Cluster Team Leads and Team Leads to ensure Adverse Events(AEs)/Serious Adverse Events(SAEs) from clinical study, non-interventional study and compassionate use sources under the scope of the CT Platform are well managed to ensure case processing quality and regulatory compliance; 
• Provide specific pharmacovigilance knowledge and experience, as required by the business, and mentor CT Platform colleagues accordingly.

Primary Responsibilities

• Efficiently manages CT Platform resources

• Organizes 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 performance

• Consolidates 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 degree preferred;
• 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.