Manager, Pharmacovigilance Data Analysis

GRIFOLS, S.A.

1d•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

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.
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.

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
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

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