Position Purpose

Review, analysis, preparation, and completion of safety-related reports within scope of the DSU to determine the safety profile of Pfizer products and to meet regulatory requirements.

Provide specific pharmacovigilance knowledge and experience, as required by the business, and mentor colleagues accordingly. Manage resources in the safety team depending on local organization and safety group size.

Primary Responsibilities

• 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
• Primary Responsibilities documentation and training, inspection preparedness, and any other required country-specific safety activity.
• When required by local regulations, and based on delegation from Country Safety Lead, act as a local QPPV/deputy local QPPV or local responsible/contact person for PV or deputy/back-up local responsible/contact person for PV.
• 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

• 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

• 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