Manager, Pharmacovigilance Data Analysis 1
Skills
About the role
This is a pharmacovigilance operations management role at Grifols in Clayton, North Carolina, supporting global drug safety systems for investigational and marketed products. It suits an experienced pharmacovigilance or database administration professional who can bridge safety business needs with IT system administration. The role manages safety database configuration, data extraction, signal management and compliance with global regulatory reporting timelines.
What you’ll do
- Support drug safety applications with business administration tasks
- Develop training documentation and work instructions for PV processes
- Coordinate and manage signal management activities
- Lead change management as the PV team adapts to new processes and application integrations
- Interact with regulatory authorities on safety database data transmission
- Ensure data consistency and integrity within the safety database
- Manage database configuration updates for submission rules, products and studies
- Supervise queries for data extraction used in periodic safety reports
- Lead the integration and establishment of the Grifols PV system
What they’re looking for
- Bachelor's degree in Biology, Chemistry, Environmental Science, Health Sciences or related discipline
- 3 years of experience in research-related roles (Biochemistry, Pharmacy or Experimental Sciences track)
- 6 years of experience in research or database administration roles (Information Technology track)
- At least 5 years of relevant pharmacovigilance experience managing databases
- Availability for international travel when necessary
Nice to have
- Familiarity with validation of computer systems and/or GMP environments
- Knowledge of E2B (R2) and E2B (R3)
- Familiarity with medical terminology, MedDRA and WHODrug
- Familiarity with reporting tools such as Business Objects
- Proficiency in both Spanish and English
- Experience in team management
Questions about this role
How many years of experience are needed?
At least 5 years of relevant pharmacovigilance experience managing databases, with education-specific tracks requiring 3-6 years.
Is this role remote?
No, it's based in Clayton, NC.
What degree is required?
A Bachelor's degree in a field within the Experimental or Health Sciences, such as Biology, Chemistry or Health Sciences.
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