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Manager, Pharmacovigilance Data Analysis

Location: NC-Clayton, US

Contract Type: Regular Full-Time

Area: R & D

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.

Occupational Demands:

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.

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.