İş Yerinde
İş Yerinde
Job Type
Full-Time
Years of Experience
4 - 6 years of experience
Department
Occupational Health and Safe...
Occupational Health and ...
Application Count
436 application
Job Type
Full-Time
Years of Experience
4 - 6 years of experience
Application Count
436 application
Department
Occupational Health and Safety
QUALIFICATIONS AND JOB DESCRIPTION
Department: Global Pharmacovigilance Office (GPO)
Reports to: Pharmacovigilance Country Lead
Role Summary
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 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
- 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
Preferred Candidate
İş Güvenliği Uzmanı pozisyonu ile ilgili daha detaylı bilgi almak ya da diğer iş fırsatlarını incelemek için aşağıdaki sayfaları inceleyebilirsiniz.
İş Güvenliği Uzmanı İş Güvenliği Uzmanı Maaşları İş Güvenliği Uzmanı Nasıl Olunur? İş Güvenliği Uzmanı Nedir? İş Güvenliği Uzmanı İş İlanlarıHakkımızda
“Pfizer, yıllık 81,3 milyar dolarlık geliri ile dünya ilaç şirketleri arasında ilk sıralarda yer alıyor.” Bugün dünyanın en büyük ilaç şirketlerind
Şirket Sayfasına Gitİş Güvenliği Uzmanı pozisyonu ile ilgili daha detaylı bilgi almak ya da diğer iş fırsatlarını incelemek için aşağıdaki sayfaları inceleyebilirsiniz.
İş Güvenliği Uzmanı İş Güvenliği Uzmanı Maaşları İş Güvenliği Uzmanı Nasıl Olunur? İş Güvenliği Uzmanı Nedir? İş Güvenliği Uzmanı İş İlanları