Posted on :
10 Oct, 2013
10 Oct, 2013
Key Performance Outputs
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 all WSRO DSU
Act as subject matter expert for the DSU within WSRO
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
Reporting Structure Reports to the Country Safety Lead
Degree or equivalent in Science/pharmacy
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
Fluency in spoken and written English
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
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
Behavioural Skills and Attributes
Commits to One Pfizer
Other Information This is a six month contract position
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