Pfizer Team Manager, Safety Officer in Wuhan, China
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 Manager, your breadth of knowledge on internal or external business challenges will help us improve our products, processes and services. Your will guide us to lead projects by meeting objectives and preparing forecasts for resource requirements. Your risk-taking ability will help us advance new concepts and methodologies. You will provide technical guidance and oversight to team members and help in problem solving.
It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Organize, manage and actively carry out as appropriate, local PV activities, such as adverse event monitoring, safety reporting, risk management, local safety monitoring activities as required by local agency, local contractual agreements, process documentation and training, inspection preparedness, and any other required country-specific safety activity
Carry out all case management activities as appropriate
Ensure regulatory compliance with timelines for individual expedited case report submissions and timely delivery of information for aggregate reports and other regulatory documents as requested
Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios
Ensure complete and timely forwarding of ICSR to Core
Determine if appropriate case follow-up has been considered. Conduct follow-up activities when needed
Consistently apply regulatory requirements and Pfizer policies
Analyze and monitor activities, define and implement corrective actions, where applicable
Develop and maintain expertise of all assigned products, of applicable corporate policies and local regulations, guidelines, Standard Operating Procedures and writing practices, of data entry conventions, and of search functions in the safety database
Provide oversight and team mentoring on case handling aspects, data extraction and analyses
Manage, where applicable, safety resources in the local team
Leverage and apply required judgment, issue resolution and negotiation skill-sets necessary to play a leadership role as a subject matter expert and/or project lead across the GPO DSU organization
Act as subject matter expert for the DSU within WWS
Act as subject matter expert for suppliers and stakeholders, locally, concerning safety-related issues; and, liaise with key partners (e.g., BUs, License Partners) regarding safety data collection and handling
Promote/participate, as appropriate, in local, internal and external safety activities
Technical Skill Requirements
Understanding and ability to use computer technology, management of relational database systems, including extraction of data
Solid working knowledge of pharmacovigilance concepts
Solid knowledge of national and international regulations
Solid understanding of medical terminology
Solid knowledge of global regulations and guidelines for drug development
Qualifications (i.e., preferred education, experience, attributes)
Health Care Professional or equivalent experience preferred
Minimum 4 years' experience in pharmacovigilance and/or data management, clinical care or clinical or scientific research required
Experience and skill with medical writing an advantage
Ability to independently solve routine problems related to case processing and surface issues constructively
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
Ability to discern when additional input is required to effectively address unique and/or complex situations
Strong skills in productivity, organizational and time management in order to meet strict regulatory compliance goals
Ability to work independently to accomplish team goals with minimal supervision
Demonstrated ability to foster teamwork
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.