Manager Database Management & Analytics, CSPV
211 Mount Airy Rd Basking Ridge, NJ 07920 US
This position manages delivery of configuration and associated validation activities of client Pharmacovigilance Systems, and fulfillment of data request. 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 PV Data Management & Analytics team in liaising with the Information Technology Informatics and Service Delivery team. This position is responsible for regular communication within local DSI CSPV teams and Global DS CSPV teams with updates to safety systems and providing status reports on various PV Systems activities. This position independently handles the complex technical problems and assists in making decisions on database-related activities.
- Act as Business Project Manager for 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 PV Suite of products.
- Liaise with the Application Managed Services (AMS) vendor in troubleshooting of IPOS Systems Oversee
- Configuration of IPOS Systems modules with the AMS Vendor:
- Interchange module- E2B R2, E2B R3 Module Argus Console Configuration AG Service Configuration ESM configuration Axway Configuration Converge
- HEALTH Safety System Configurations
- Provide business requirements and recommendations 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.
- Manage Implementation and documentation of Change Request supporting documents and evidences
- Review of Change Request, supporting documents and evidences
- 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
- Management of KPIs Create and maintain schedules for CSPV System Projects
- Status reports on the projects
- Maintain compliance with relevant policies and procedures
- Experience with administration of Argus Safety 8.x
- 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
- 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
- Ability to exhibit project management skills
- High level of proficiency with MS Office applications
- Solid written, verbal communication, and interpersonal skills
- Bachelor's degree in technical field
- Minimum of six years of experience in Drug Safety and Pharmacovigilance.
- Three years of experience specific to managing PV System Implementation and validation processes, database business configuration, and data querying.
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