Pharmacovigilance Data Analysis Manager

Grifols Shared Services North America, Inc

Ireland

On-site

EUR 65,000 - 90,000

Full time

11 days ago

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Benefits offered by this job

Salary

Bonus

Share options

Pension

Medical insurance

Career development

Education assistance

Wellness programs

Team environment

Job summary

Grifols is seeking an experienced Pharmacovigilance professional to oversee safety data analysis, system administration and regulatory reporting, ensuring high-quality deliverables. You will partner with IT, QA and regulatory teams to implement improvements.

The role requires 4+ years in pharmacovigilance, strong writing and communication skills, and expertise with PV databases, regulatory guidelines, and reporting tools. Fluency in English and Spanish is required.

Qualifications

Bachelor's degree in Health Sciences or Bioscience with relevant training.
At least 4 years of pharmacovigilance experience including database management.
Knowledge of Good Pharmacovigilance Practices and regulatory guidelines.

Responsibilities

Lead and coordinate safety data analysis for aggregate reports and signal management.
Support PV systems with admin tasks including configuration updates and testing with authorities.
Manage PV documentation: SOPs, WPs, requirements, specifications and process flow diagrams.
Drive change management and adoption of new PV processes and applications.

Skills

Pharmacovigilance experience

GVP knowledge

MS Office

Languages: English & Spanish

Technical writing

Analytical skills

Communication & collaboration

Prioritization & organization

Education

Bachelor's in Health Sciences

Bioscience degree

Tools

Business Objects

Power BI

R (bioinformatics)

MedDRA/WhoDrug knowledge

Job description

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.

At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment.

Position Summary

The employee occupying this position will perform activities in accordance with the Pharmacovigilance System Master File (PSMF), Standard Operating Procedures (SOPs), Working Practices (WPs), and applicable pharmacovigilance legislation. Ensures that pharmacovigilance deliverables are of the highest quality and meet global regulatory reporting timelines. Responsible for project implementation and execution of systems, including providing ongoing safety business support and continuous improvements. Acts as a key interface with IT system administrators to validate and test system changes, ensuring the system remains compliant and meets business requirements.

What You’ll Do

Lead and coordinate safety data analysis for aggregate reports preparation, signal management and ad hoc requests.
Support drug safety systems through business administration tasks, including database configuration updates, submission rules management and testing with regulatory authorities.
Serve as a subject matter expert in delivering and evaluating cost-effective, sustainable solutions that meet business requirements.
Manage documentation related to PV systems and applications, including SOPs, WPs, user requirements, functional/ technical specifications and process flow diagrams.
Drive change management initiatives to ensure smooth adoption of new processes and support the integration of new applications within the PV team.
Collect, prioritize and plan system improvements based on user feedback, while ensuring compliance with regulatory requirements.
Act as the primary PV contact for IT-related PV projects.
Drive Innovation through AI in Pharmacovigilance: Stay at the forefront of artificial intelligence advancements to identify and evaluate innovative technologies and processes that can enhance pharmacovigilance operations. This includes proactively assessing AI-driven tools and methodologies to improve signal detection, case processing, data analysis and regulatory compliance. Collaborate cross-functionally to pilot and implement solutions that increase efficiency, accuracy, and strategic value in safety monitoring.

Who you are

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

You have a bachelor's degree in Health Sciences (pharmacy, nursing, medicine, veterinary, etc) or Bioscience (biochemistry, biotechnology, biology, etc). Additional training and/or experience in bioinformatics/biostatistics or data analysis tools (such as R or Power BI).
You have at least 4 years of pharmacovigilance experience including management of pharmacovigilance data bases.
You have proven knowledge of Good Pharmacovigilance Practices; existing legislation, regulations, guidelines, medical coding and safety-data administration.
You are proficient in Windows and MS Office (Excel, PowerPoint, Visio, Word).
Familiarity with reporting tools such as Business Objects is strongly preferred.
You have knowledge of E2b (R2) and E2b (R3) and to be familiarity with medical terminology, MedDRA, WhoDrug are a plus.
You speak fluent Spanish and English.
You are proven self-starter with strong work ethic and the ability to exercise good judgment.
You 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.
You 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.