Associate Director, Safety Data Management

Position Summary

Oversees the Change Management Process of GSDM and GPV Help desk to monitor reported incident and change requests. Maintain and manage safety systems used by GPV.

Key Job Responsibilities

• Responsible for maintaining data and system configurations for safety systems in accordance with Otsuka methodologies, applying knowledge of technology, regulations, policies, processes and/or procedures to control and maintain accurate records.
• Responsible for maintaining the validated state of systems by overseeing validation tasks across the GSDM team and in close interaction with Otsuka Testing and Validation teams.
• Work closely with all GPV functional areas to develop solutions, work plans and oversee their implementation, including but not limited to gathering, business requests for safety systems, changes and upgrades.  Provide subject matter expertise for safety system upgrades and changes.
• Responsible for managing offshore support team and coordinate their daily activities.
• Responsible for producing weekly performance metrics quantifying the support work.
• Assist in defining, designing, developing, testing and deploying systems.
• Manage system incidents, changes and problems by application of Otsuka and industry best practices.
• Ensure timely and appropriate escalation of risk, issues and concerns to the GSDM leadership.
• Provide accurate timely reports on the status of incidents, changes, problems and assigned projects.
• Demonstrated experience in conducting E2B pilots with Regulatory Agencies and partners.
• Support GPV Business intelligence in the development, validation and management of necessary line-listings, aggregate summaries, data exports or customized reports from safety data sources.
• Provide/support user training on safety systems.
• Perform other tasks as assigned.

Knowledge, Skills, Competencies, Education, and Experience

Required:

Knowledge

• Minimum 5 years of Pharmacovigilance / Drug Safety experience or equivalent required with subject matter expertise in software-based drug safety systems, direct experience with  Argus highly desired
• Both pre-approval and post-marketing experience in a global environment highly desired.
• Strong knowledge of pharmaceutical/biotech industry and the overall drug development process
• Knowledge of relevant FDA, EU, MHLW, Health Canada and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing safety environments
• Understanding and familiarity of the drug development process
• Knowledge of MedDRA and WHO-DD coding dictionary

Skills

• In depth knowledge of PL/SQL, Oracle 9i/10g/11g, SQL Server, Argus suite, TOAD, Sql Developer
• Experience in tools; JReport ver 12, 13.1
• Computer skills including proficiency in the use of Microsoft Word, Excel, Access and PowerPoint.
• Excellent oral and written English communication skills

Education and Related Experience

• BS degree in a life sciences field with minimum of 4 years of experience in the pharmaceutical industry.

Physical Demands and Work Environment

Travel (approximately 10%)

Disclaimer

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Equal Opportunity Employer

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.