Associate Director, PV Standards – Governance
CSL
full-time
Posted on:
Location Type: Hybrid
Location: King of Prussia • Pennsylvania • 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- Maintain PV data standards, taxonomies, and controlled vocabularies with global regulatory requirements (e.g., ICH, EMA, FDA)
- Lead governance of PV data and processes, ensuring consistency and standardization across systems, studies, and functions
- Collaborate with teams (e.g., Safety, Regulatory, Clinical, IT) to embed PV data standards into systems and workflows across the organization
- Monitor compliance with PV standards, identifying opportunities for improvement and driving quality enhancements
- Represent us in external standards bodies and industry forums (e.g., ISO IDMP, ICH) to ensure understanding of global standards and industry best practices
- Support audits, inspections, and regulatory submissions by ensuring traceability, documentation, and adherence to PV standards
- Provide training and guidance to teams on PV data standards and governance practices, promoting a culture of compliance and continuous improvement
Requirements
- Bachelor's degree in Life Sciences, Pharmacy, Public Health, or a related field
- 10+ years of experience in pharmacovigilance, safety data management, or regulatory affairs
- Knowledge of global PV regulations, data standards (e.g., MedDRA, WHODrug), and safety systems (e.g., Argus, ArisGlobal)
- Experience in data governance, quality management, or standards development, with a focus on regulatory compliance
Benefits
- Medical
- Dental
- Vision
- 401K
- Paid time Off
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
pharmacovigilancesafety data managementregulatory affairsdata governancequality managementstandards developmentglobal PV regulationsdata standardscompliance monitoringdocumentation
Soft skills
leadershipcollaborationcommunicationtrainingguidancequality enhancementcontinuous improvementorganizational skillsproblem-solvinginterpersonal skills