Manager, Pharmacovigilance Data Analysis
GRIFOLS, S.A.•NC-Clayton, CA
•Onsite
About The Position
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.
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.
Nice To Haves
- 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
- Proficiency in both Spanish and English is preferred
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
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What This Job Offers
Job Type
Full-time
Career Level
Manager
