Mgr Safety Systems

Join a Legacy of Innovation 110 Years and Counting!

With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group's 2025 Vision to become a "Global Pharma Innovator with a Competitive Advantage in Oncology," Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.

Job Summary:

This position supports the PV Data Management & Analytics team in database validation and configuration activities, and in the fulfillment of data requests. The position acts as the DSI CSPV Local Implementation Vendor for all database validation and configuration activities, including documenting and reviewing global validation evidences, and leading/overseeing all PQ activities. This position assists in developing team querying/reporting activities in support of CSPV, other department, and regulatory requests, including Aggregate Safety Reports. This position is responsible for regular communication within local DSI CSPV teams and Global DS CSPV teams with updates safety systems. This level independently handles the most complex technical problems and assists in making decisions on database-related activities.

Responsibilities:

Application Support:

• Support the day-to-day running of IPOS Systems to sustain CSPV Objectives
• Manage IPOS Systems installation, configuration and integration with different Argus Suite of products.
• Troubleshooting of IPOS Systems
• Coordinate Configuration of IPOS Systems modules:
  • Interchange module- E2B R2, E2B R3 Module
  • Argus Console Configuration
  • AG Service Configuration
  • ESM configuration
  • Axway Configuration
  • ConvergeHEALTH Safety System Configurations
• Managing customer reported issues on IPOS Systems including troubleshooting, liaising with Global Application Support team and helpdesk.
• Manage validation of IPOS Systems patches.
• Provide technical assistance around IPOS Systems configuration.
• Working in coordination with Global AMS team on Oracle SRs.
• Support Drug Safety Dictionary version management, such as MedDRA, WHO dictionaries, and upgrades as required by CSPV Operations.

Change Requests:

• Collaborate Cross functionally to understand and analyze the scope of change.
• Take part in impact analysis of changes to IPOS Systems identifying the risks, benefits and assist with assessing the costs associated with the change.
• Suggest alternate solutions and provide technical recommendations for Changes
• Manage Implementation and documentation of Change Request supporting documents and evidences
• Peer review Change Request supporting documents and evidences

KPI Management:

• Measure the KPIs on periodic basis
• Perform trend analysis, report on the KPIs and trends
• Coordinate with Quality and Compliance group to take necessary action on the trends
• Document KPI Reports

Other:

• Maintain compliance with relevant policies and procedures
• Support the investigation and resolution of complex, cross-functional issues using strong problem solving abilities

Qualifications

Education and Experience

• Bachelor's degree in technical field
• Minimum of six years of experience in Drug Safety and Pharmacovigilance. Three years of experience specific to database validation processes, database business configuration, and data querying.

Competencies

• Experience with administration of Argus Safety 8.1.1, 8.1 and 8.0.x, 7.0.x Patches.
• Experience with SQL programming/querying, custom report design/development from Argus Safety backend database.
• Strong knowledge of ConvergeHEALTH Safety Reporting module is preferred
• Proficient ability to identify issues independently and thoroughly understands the causes of those issues; understands the impact within the team; provides suggestions for resolution and implements solutions
• Has a comprehensive understanding of the functional roles within Pharmacovigilance and Clinical Trials
• Ability to extract configurable data fields from a study protocol
• Proficient in FDA regulations supporting the submission of adverse events for post-marketing and investigative drugs. Understanding of global regulations preferred
• Good knowledge of Good Documentation Practices and global Data Entry conventions.
• Effectively manages shifting priorities; skillfully aligns resources as applicable to priorities that require immediate action
• Understanding of ICH guidelines on Pharmacovigilance
• Understanding of MedDRA structure
• Understanding and application of guidelines detailed in FDA 21 CFR Part 11, including system validation requirements
• Advanced understanding of database architecture (Argus Safety Database required, of ConvergeHEALTH Safety Reporting module preferred)
• Ability to troubleshoot complex problems, involve multiple teams/departments in the investigation and assessment of the problem and proposed solutions.
• High level of proficiency with MS Office applications
• Solid written, verbal communication, and interpersonal skills
• Time management and ability to prioritize workload
• Quality orientation: attention to detail, accuracy
• Ability to exhibit project management skills

Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Job Title
Mgr Safety Systems

City
Basking Ridge

Functional Area
CSPV

State
New Jersey