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(Pharmacovigilance) Drug Safety Officer
•30 days ago
| Hours | Full-time, Part-time |
|---|---|
| Location | new york, New York |
About this job
Org Marketing Statement
A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Role Description
Review, analysis, preparation, and completion of safety-related reports within scope of the DSU to determine the safety profile of Pfizer's 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
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 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 WSR
* 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
Qualifications
* 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
* 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
* 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
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Role Description
Review, analysis, preparation, and completion of safety-related reports within scope of the DSU to determine the safety profile of Pfizer's 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
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 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 WSR
* 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
Qualifications
* 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
* 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
* 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
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
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