Manager, Safety Systems

Location
Basking Ridge, NJ, United States
Posted
Oct 31, 2020
Ref
10532BR
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time
~~Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 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 cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Job Summary:

This position supports the PV Data Management & Analytics team in coordinating configuration and associated validation activities of Daiichi Sankyo PV Systems, and in the fulfillment of data requests. The position acts as the Clinical Safety and Pharmacovigilance (CSPV) Local Liaison for configuration activities, including reviewing global validation evidences, and leading/overseeing 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 position independently handles the most complex technical problems and assists in making decisions on database-related activities.

Responsibilities:

Application Management:
• Act as Business Project Manager for all technology implementations in CSPV Department
• Manage and oversee the day-to-day running of IPOS Systems to sustain CSPV Objectives
• Act as Business representative on IPOS Systems installation, configuration and integration with different Argus Suite of products.
• Liaise with the Application Managed Services (AMS) vendor in troubleshooting of IPOS Systems
• Liaise Configuration of IPOS Systems modules with the AMS Vendor:
o Interchange module- E2B R2, E2B R3 Module
o Argus Console Configuration
o AG Service Configuration
o ESM configuration
o Axway Configuration
o ConvergeHEALTH Safety System Configurations
• Provide business requirements and recommendations around IPOS Systems configuration.
• Working in coordination with Global AMS team on Oracle SRs.

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
• Review of 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: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/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.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. 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
Manager, Safety Systems

City
Basking Ridge

Functional Area
CSPV

State
New Jersey