Job title: Associate Manager, Pharmacovigilance Quality & Compliance (New Consumer Health Company)
Company: Johnson & Johnson
Job description: Job Description:
Johnson & Johnson is currently recruiting an Associate Manager, Pharmacovigilence (PV) Quality & Compliance (New Consumer Health Company). This position may be located in Paranaque, Philippines, or Mulund, Mumbai, India.
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 innovative ideas, products and services to advance the health and well-being of people.
With $82.1 billion in 2020 sales, Johnson & Johnson is the world’s most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. Johnson & Johnson is the world’s most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices & diagnostics markets and have the skills and resources to tackle the world’s most pressing health issues.
Johnson & Johnson announced plans to separate our Consumer Health business to create a new publicly traded company. The process of the planned separation is anticipated to be completed within 24 months, and it will be subject to legal requirements including consultation with works councils and other employee representative bodies, as required, and other customary conditions and approvals.
It is anticipated that, following conclusion of the transaction, this position may be conveyed with New Consumer Health. In that case, details of any planned changes would be provided to the successful candidate by New Consumer Health at an appropriate time and would be subject to any necessary consultation processes.
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 the 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
Qualifications
Required:
Fluency in the national language(s) and the English language
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
Preferred:
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
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
Requires problem solving skills to interpret data & information, analyze, and make recommendations
Experience developing and conducting presentations for different levels of management; ability to tailor presentations to the appropriate level of detail
Primary Location
Philippines-National Capital-Manila-
Other Locations
Asia Pacific-India-Maharashtra-Greater Mumbai
Organization
Johnson & Johnson International (Singapore) Pte. Ltd. – ROHQ
Job Function
R&D
Requisition ID
2206070911W
Expected salary:
Location: Manila City, Metro Manila – Mumbai, Maharashtra
Job date: Thu, 01 Sep 2022 22:52:45 GMT
Apply for the job now!
