Job Description
We are seeking an experienced and driven professional to lead our Global Administration Team, with primary responsibility for the oversight, maintenance, and continuous improvement of our Global Product Dictionary within our pharmacovigilance systems. This role is critical to ensuring the accuracy, consistency, and regulatory compliance of product registration data used in adverse event reporting and safety surveillance across all markets.
Key Responsibilities - Leadership and Oversight
- Lead and mentor a global team of product dictionary administrators, ensuring high performance and alignment with safety and regulatory objectives.
- Serve as the primary point of contact for all product dictionary related matters across global pharmacovigilance and regulatory operations.
- Product Dictionary Management
- Oversee the creation, update, and maintenance of product entries, including product names, formulations, license information, and regulatory codes.
- Ensure timely integration of new product launches, label changes, and regulatory updates into the dictionary.
- Compliance and Data Integrity
- Ensure product data complies with global regulatory standards (e.g., VICH, FDA, EMA, USDA).
- Maintain alignment with global product common names and product definitions.
- Cross-Functional Collaboration
- Collaborate with Regulatory Affairs, IT, and other stakeholders to ensure accurate and consistent product data across systems.
- Support audits and inspections by providing documentation and subject matter expertise on product dictionary processes.
- Process Improvement and Documentation
- Collaborate with PV Training Coordinator to develop and maintain SOPs, work instructions and training materials related to the product dictionary.
- Identify opportunities for automation, standardization, and efficiency improvement in dictionary workflows.
- Training and Support
- With the PV Training Coordinator, provide training and guidance to internal stakeholders on product dictionary usage and best practices.
- Act as a liaison between database users and IT for issue resolution and enhancements.
Qualifications - Bachelor's degree in Life Sciences, Pharmacy, or a related field required.
- Minimum 3-5 years of experience in pharmacovigilance, regulatory operations, or at least 2 years in a database role.
- Proven leadership or team management experience in a global or matrixed environment.
- Strong understanding of global pharmacovigilance regulations and database standards.
Preferred Skills - Experience with database tools.
- Excellent organizational and communication skills.
- Ability to manage multiple priorities in a fast-paced, global environment.
Full time
Regular
Colleague
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Job Tags
Full time, Local area,