Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing creative ideas, products and services to advance the health and well-being of people. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.
Post : Associate Manager, Pharmacovigilance Quality & Compliance (New Consumer Health Company)
Job Description :
Role & Responsibilities :
The Associate Manager, PV Compliance and Quality Oversight, is primarily responsible for the day-to-day Compliance Strategy and Analytics (CSA) Individual Case Safety Report (ICSR) core End of Line Quality (EOLQ) review process, investigating and documenting late ICSR, Aggregate Report and ESI/SSI submissions to Health Authorities, monitoring the timely exchange of ICSRs with Alliance Partners and monitoring inbound ICSR performance from multiple sources. The Associate Manager is responsible for overseeing the generation, quality review, and distribution of compliance and quality metrics and trending activities. Participates in audits and inspections as Subject Matter Expert for PV Compliance and Quality activities. Performs User Acceptance Testing of reports, and visualizations as necessary. Participates in or leads cross-functional compliance, quality, and process improvement initiatives. Provides input into corrective/preventative actions and effectiveness measures for CAPAs, as appropriate. Responsible for resolving issues related to day-to-day activities independently and to determine when to escalate issues to senior management. May be responsible for oversight of vendor resources performing services on behalf of CSA.
Key Responsibilities :
Investigations of Late Health Authority and Alliance Partner Submissions
• Investigates late ICSR, Aggregate Report, ESI/SSI submissions to Health Authorities (HA)
• Documents, monitors, and trends reasons for late submissions. Opens Quality Investigations for identified trends
• Monitors Inbound and Outbound PVA compliance to Alliance Partners (AP) and documents reasons for lateness where the threshold is met, or late exchange causes late Health Authority Submissions to Health Authorities
• Analyzes trends for reasons of late submissions to HA or AP
• Opens Quality Investigation when a trend is identified
• Works with key stakeholders to ensure robust corrective/preventative and effectiveness checks are implemented
• Monitors ICSR inbound performance from multiple sources to drive high HA compliance. Opens QI when trends are identified
Generation and distribution of PV Compliance and Quality Metrics
• Generates, quality reviews, and distributes compliance and quality metrics for the oversight of the Quality Management System
• Collaborates with key stakeholders to ensure metrics meet oversight needs
• Develop, review, implement and quality review or validate new metrics presentations, visualizations, and reports
Operational Performance Analysis
• Manages the PV Quality Review Process
• Coordinates with Compliance Senior Management and QPPV to ensure consistent fulfillment of the global PV obligations
• Partners with the operations teams, global case processing centers, and Local Operating Companies / Local Safety Officers to develop strategies for quality and compliance improvements
• Partners with internal stakeholders to monitor vendor quality
• Investigates and documents scores below quality thresholds
• Manages responses to Health Authority Data Quality Reports
Candidate Profile :
• Fluency in the national language(s) and the English language is required.
• A minimum of a Bachelor's Degree in a relevant discipline (Business, Science, Medical, Operations, etc.) with 8 years of pharmaceutical industry experience or an advanced academic degree with 5 years of pharmaceutical industry experience
• Minimum of 5 years of experience in PV and/or PV compliance monitoring
• Knowledge of global PV laws and regulations
• Experience in participation, management, or conduct of audits/inspections
• Proficiency in Microsoft Excel and SharePoint
• Knowledge of GxP requirements and experience with safety processing, clinical study safety reporting, PV, and medical information
• Ability to function in a global matrix environment
• Excellent communication and writing skills
• Ability to lead global work streams, drive teams to make decisions, achieve deliverables and manage and resolve issues independently
• Understanding of and experience with multi-cultural working is preferred
• Ability to evaluate processes and procedures against outcomes to identify methods to improve efficiency, accuracy, and compliance
• Ability to utilize appropriate initiative and autonomy in achieving objectives
• Excellent track record with negotiation and collaboration
• Project Management experience with organizing actions and managing team activities is preferred
• Requires problem-solving skills to interpret data & information, analyze, and make recommendations
• Experience developing and conducting presentations for different levels of management with the ability to tailor presentations to the appropriate level of detail
Additional Information :
Experience : 5-8 years
Qualification : Bachelor's Degree
Location : Greater Mumbai, India
Industry Type : Pharma
Functional Area : Pharmacovigilance Quality & Compliance
End Date : 30th September, 2022
See All Mumbai Alerts B.Pharm Alerts M.Pharm Alerts M.Sc Alerts
See All Other Jobs in our Database
.png)
