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Associate Director, Safety Data Management

4+ years
Not Disclosed
10 Dec. 13, 2024
Job Description
Job Type: Full Time Education: BS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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Position Summary

The Change Management Lead for the GSDM and GPV Help Desk is responsible for monitoring reported incidents and change requests while maintaining and managing GPV safety systems. This role ensures seamless system configurations and validated operations, supporting the organization’s mission to deliver excellence in Pharmacovigilance.


Key Responsibilities

System Maintenance & Configuration

  • Manage and maintain safety system data and configurations per Otsuka standards, ensuring accuracy and regulatory compliance.

  • Oversee system validation tasks, collaborating with Testing and Validation teams.

  • Ensure safety systems remain in a validated state, supporting both daily operations and long-term strategies.

Change Management & Support

  • Act as a subject matter expert for safety system changes, upgrades, and enhancements.

  • Oversee incident, change, and problem management using industry best practices.

  • Manage offshore support teams, ensuring alignment with daily activities and goals.

  • Monitor and report weekly performance metrics to quantify support efficiency.

Collaboration & Development

  • Work cross-functionally with GPV teams to gather and address business needs for system upgrades and solutions.

  • Support GPV Business Intelligence by creating and validating safety data reports, line-listings, and aggregate summaries.

  • Develop and deliver user training programs on safety systems.

System Implementation & Oversight

  • Define, design, test, and deploy safety system solutions.

  • Conduct E2B pilots with regulatory agencies and partners to ensure compliance and innovation.

  • Support the development of system-related research initiatives and deliver results effectively.

Risk Management & Reporting

  • Escalate risks and issues to GSDM leadership promptly and effectively.

  • Provide accurate and timely reporting on incidents, changes, and project statuses.


Knowledge, Skills, and Competencies

Required Knowledge

  • At least 5 years of experience in Pharmacovigilance/Drug Safety, with expertise in software-based safety systems (Argus experience preferred).

  • In-depth understanding of clinical trial and post-marketing safety environments in a global setting.

  • Familiarity with FDA, EU, MHLW, Health Canada, and ICH guidelines.

  • Knowledge of MedDRA and WHO-DD coding dictionaries.

Skills

  • Proficiency in PL/SQL, Oracle, SQL Server, Argus Suite, TOAD, and SQL Developer.

  • Experience with tools like JReport (ver 12/13.1).

  • Strong presentation, communication, and project management skills.

  • Advanced computer skills in Microsoft Word, Excel, Access, and PowerPoint.

Education and Experience

  • Bachelor's degree in Life Sciences or related field.

  • Minimum 4 years of experience in the pharmaceutical industry.

  • Experience with pre- and post-marketing in a global environment is highly desired.


Competencies

  • Accountability for Results: Focus on strategic objectives and drive high standards of performance.

  • Strategic Thinking & Problem Solving: Make decisions considering long-term business impacts.

  • Patient & Customer Centricity: Prioritize the needs of patients, customers, and stakeholders.

  • Impactful Communication: Effectively influence and inspire across all organizational levels.

  • Respectful Collaboration: Value diverse perspectives and work towards common goals.

  • Empowered Development: Actively pursue personal and team growth opportunities.


Additional Information

Travel Requirements: Approximately 10%.
Work Environment: Otsuka provides a supportive environment that fosters innovation and collaboration.

Equal Opportunity Employer
Otsuka is committed to diversity and inclusion, welcoming applicants from all backgrounds and providing equal employment opportunities.

Beware of Recruitment Fraud
Otsuka never asks for payment or financial information during the hiring process. If you encounter suspicious recruitment activities, report them to the FBI or your local authorities.


Why Join Otsuka?

  • Make a Difference: Contribute to improving patient lives with innovative solutions.

  • Global Collaboration: Be part of a team that values diversity and empowers local decision-making.

  • Career Growth: Access extensive opportunities for professional development and global mobility.

For more information, visit Otsuka Careers.