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Job Details

Skills

Data Analysis
Health Care
Regulatory Reporting
Project Implementation
Business Administration
Instructional Design
Documentation
Specification Gathering
Process Flow
Change Management
Data Extraction
Regulatory Compliance
Project Management
Work Ethic
Supervision
Attention To Detail
Analytical Skill
Problem Solving
Conflict Resolution
SAP BASIS
Technical Writing
Communication
Test Scripts
Microsoft Operating Systems
Microsoft Windows 7
Microsoft Excel
Microsoft PowerPoint
Microsoft Visio
GMP
SAP R/3
Medical Terminology
MedDRA
Reporting
Business Objects
Team Management
Collaboration
Organized
Training
Strategic Planning
Database
Oracle
Spanish
English
Biology
Chemistry
Biochemistry
Pharmacy
Science
Information Technology
Research
Database Administration
Management
Recruiting

Data Analysis
Health Care
Regulatory Reporting
Project Implementation
Business Administration
Instructional Design
Documentation
Specification Gathering
Process Flow
Change Management
Data Extraction
Regulatory Compliance
Project Management
Work Ethic
Supervision
Attention To Detail
Analytical Skill
Problem Solving
Conflict Resolution
SAP BASIS
Technical Writing
Communication
Test Scripts
Microsoft Operating Systems
Microsoft Windows 7
Microsoft Excel
Microsoft PowerPoint
Microsoft Visio
GMP
SAP R/3
Medical Terminology
MedDRA
Reporting
Business Objects
Team Management
Collaboration
Organized
Training
Strategic Planning
Database
Oracle
Spanish
English
Biology
Chemistry
Biochemistry
Pharmacy
Science
Information Technology
Research
Database Administration
Management
Recruiting

Summary

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Summary:

Provides operational support for global pharmacovigilance activities for Grifols investigational and marketed products. Ensures pharmacovigilance deliverables are of the highest quality and meet global regulatory reporting timelines. Responsible for project implementation and execution of system, including responsibilities for providing safety ongoing business support and ongoing improvements. Key interface with the IT system administrators to verify and test system changes ensuring that the system is compliant and meets business needs.

Responsibilities:

Support drug safety applications with business administration tasks
Key expert to deliver solutions that are cost effective, sustainable, and meet business requirements
Develop training documentation and/or work instructions to determine methods and procedures
Coordination and management of signal management
Management of documentation describing PV applications use, which may include, but not limited to: SOPs, WP, User requirements, functional and/or technical specifications, process flow diagrams
Lead change management actions to assure PV team smoothly adapts to the new processes, as well as supporting the integration of a new application
Interact with Regulatory Authorities as it relates to safety database data transmission
Gathering, prioritizing, and planning improvements based on user requests, considering overall regulations to the business
Ensure data consistency and integrity within the safety database
Management and coordination of the updates in the database configuration of submission rules to Regulatory Authorities
Management and coordination of the updates in the database configuration of products and studies
Supervision and management of queries for data extraction used in different PV documents
Supervision and management of queries into the database to identify the interval and cumulative cases to be included in periodic reports
Supervision and management for obtaining case listings from the database for specific situations
Supervision and management of IT tickets needed for system compliance and improvements
Planning and prioritizing scheduled IT tickets
Project lead on the integration and establishment of the Grifols PV system

Knowledge, Skills, & Abilities:

Proven Self-starter with strong work ethic and the ability to exercise good judgment.
Ability to work independently with minimum supervision.
Must be proactive, results oriented, and have strong attention to detail.
Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis.
Strong interpersonal skills with the ability to interact and collaborate with personnel at all levels in a team environment.
Must possess strong technical writing and communication skills with ability to create and present design proposals, test scripts, execute training sessions and conduct effective meetings.
Ability to effectively prioritize and manage multiple tasks to ensure successful completion targeted deadlines
Proficient in Windows 7 and MS Office (Excel, PowerPoint, Visio, Word)
Familiarity with validation of computer systems and/or GMP environments is essential.
Knowledge of E2b (R2) and E2b (R3) is beneficial. Familiarity with Medical terminology, MedDRA, WhoDrug is beneficial
Familiarity with reporting tools such as Business Objects is strongly preferred
Experience in team management.
Scientific expertise.
Planning and cross-functional collaboration skills and organized work habits.
Education or training in Information Technology or New Technologies, with knowledge of Systems Strategic Planning.
Databases and Spreadsheets Programming skills
Skilled in Oracle Analysis
Proficiency in both Spanish and English is preferred

Requirements:

Bachelor's degree in a field within the Experimental or Health Sciences (e.g., Biology, Chemistry, Environmental Science, Health Sciences, or a related discipline).
Biochemistry, Pharmacy, or Experimental Sciences - 3 years of experience in research-related roles
Information Technology (Database Administration) - 6 years of experience in research or database administration roles
At least 5 years of relevant experience in pharmacovigilance managing data bases. Availability for international travelling when necessary is also required.
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience.

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.

Location: NORTH AMERICA : EE.UU. : NC-Clayton:USNC0002 - Clayton

Learn more about Grifols

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: RTX1d2c20
Position Id: c3b5c4657ec9ce3610788e1f0b0ad4af
Posted 5 hours ago

Job Details

Skills

Data Analysis
Health Care
Regulatory Reporting
Project Implementation
Business Administration
Instructional Design
Documentation
Specification Gathering
Process Flow
Change Management
Data Extraction
Regulatory Compliance
Project Management
Work Ethic
Supervision
Attention To Detail
Analytical Skill
Problem Solving
Conflict Resolution
SAP BASIS
Technical Writing
Communication
Test Scripts
Microsoft Operating Systems
Microsoft Windows 7
Microsoft Excel
Microsoft PowerPoint
Microsoft Visio
GMP
SAP R/3
Medical Terminology
MedDRA
Reporting
Business Objects
Team Management
Collaboration
Organized
Training
Strategic Planning
Database
Oracle
Spanish
English
Biology
Chemistry
Biochemistry
Pharmacy
Science
Information Technology
Research
Database Administration
Management
Recruiting

Data Analysis
Health Care
Regulatory Reporting
Project Implementation
Business Administration
Instructional Design
Documentation
Specification Gathering
Process Flow
Change Management
Data Extraction
Regulatory Compliance
Project Management
Work Ethic
Supervision
Attention To Detail
Analytical Skill
Problem Solving
Conflict Resolution
SAP BASIS
Technical Writing
Communication
Test Scripts
Microsoft Operating Systems
Microsoft Windows 7
Microsoft Excel
Microsoft PowerPoint
Microsoft Visio
GMP
SAP R/3
Medical Terminology
MedDRA
Reporting
Business Objects
Team Management
Collaboration
Organized
Training
Strategic Planning
Database
Oracle
Spanish
English
Biology
Chemistry
Biochemistry
Pharmacy
Science
Information Technology
Research
Database Administration
Management
Recruiting

Summary

Support drug safety applications with business administration tasks
Key expert to deliver solutions that are cost effective, sustainable, and meet business requirements
Develop training documentation and/or work instructions to determine methods and procedures
Coordination and management of signal management
Management of documentation describing PV applications use, which may include, but not limited to: SOPs, WP, User requirements, functional and/or technical specifications, process flow diagrams
Lead change management actions to assure PV team smoothly adapts to the new processes, as well as supporting the integration of a new application
Interact with Regulatory Authorities as it relates to safety database data transmission
Gathering, prioritizing, and planning improvements based on user requests, considering overall regulations to the business
Ensure data consistency and integrity within the safety database
Management and coordination of the updates in the database configuration of submission rules to Regulatory Authorities
Management and coordination of the updates in the database configuration of products and studies
Supervision and management of queries for data extraction used in different PV documents
Supervision and management of queries into the database to identify the interval and cumulative cases to be included in periodic reports
Supervision and management for obtaining case listings from the database for specific situations
Supervision and management of IT tickets needed for system compliance and improvements
Planning and prioritizing scheduled IT tickets
Project lead on the integration and establishment of the Grifols PV system

Knowledge, Skills, & Abilities:

Proven Self-starter with strong work ethic and the ability to exercise good judgment.
Ability to work independently with minimum supervision.
Must be proactive, results oriented, and have strong attention to detail.
Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis.
Strong interpersonal skills with the ability to interact and collaborate with personnel at all levels in a team environment.
Must possess strong technical writing and communication skills with ability to create and present design proposals, test scripts, execute training sessions and conduct effective meetings.
Ability to effectively prioritize and manage multiple tasks to ensure successful completion targeted deadlines
Proficient in Windows 7 and MS Office (Excel, PowerPoint, Visio, Word)
Familiarity with validation of computer systems and/or GMP environments is essential.
Knowledge of E2b (R2) and E2b (R3) is beneficial. Familiarity with Medical terminology, MedDRA, WhoDrug is beneficial
Familiarity with reporting tools such as Business Objects is strongly preferred
Experience in team management.
Scientific expertise.
Planning and cross-functional collaboration skills and organized work habits.
Education or training in Information Technology or New Technologies, with knowledge of Systems Strategic Planning.
Databases and Spreadsheets Programming skills
Skilled in Oracle Analysis
Proficiency in both Spanish and English is preferred

Requirements:

Bachelor's degree in a field within the Experimental or Health Sciences (e.g., Biology, Chemistry, Environmental Science, Health Sciences, or a related discipline).
Biochemistry, Pharmacy, or Experimental Sciences - 3 years of experience in research-related roles
Information Technology (Database Administration) - 6 years of experience in research or database administration roles
At least 5 years of relevant experience in pharmacovigilance managing data bases. Availability for international travelling when necessary is also required.
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience.

Dice Id: RTX1d2c20
Position Id: c3b5c4657ec9ce3610788e1f0b0ad4af
Posted 5 hours ago

IT/OT Lab Specialist

Durham, North Carolina

•

Today

Job Description Summary Imagine being the technology partner who keeps critical laboratory operations running smoothly, compliantly, and efficiently every day. As an IT/OT Lab Specialist at Novartis, you will play a key role in supporting the computerized systems and laboratory technologies that enable scientific innovation and operational excellence. You'll work alongside cross-functional teams to ensure reliable system performance, maintain compliance with regulatory requirements, and help del

Full-time

USD 98,700.00 - 183,300.00 per year

Manager, Pharmacovigilance Data Analysis 1

Skills

Summary

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Manager, Pharmacovigilance Data Analysis 1

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