Johnson & Johnson Private Limited Hiring 2022. Johnson & Johnson Private Limited Notification full details below.Interested and eligible candidates can Apply Now .Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
- Post Name: Associate Manager, Pharmacovigilance Quality & Compliance (New Consumer Health Company)
- Qualification: 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
- Experienced: Minimum of 5 years of experience in PV and/or PV compliance monitoring
Job Description: Johnson & Johnson Private Limited Hiring For Associate Manager, Pharmacovigilance Quality & Compliance (New Consumer Health Company) !
Important Details :
- Post of date:02/09/2022
- Location: Asia Pacific-India-Maharashtra-Greater Mumbai Organization
- Selection Process: The selection will be on the basis of Interview.
Roles and 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.
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
How to Apply :
Step 1: Click on below link and you will be redirected to Career Page of Recruiting Company or Career portal.
Step 2. Register on Career Page of the Company or Career Portal by giving log in credentials and other personal or education details .
Step 3.Upon successful registration .User need to log in with credentials.
Step 4.Once logged in, User need to fill the all relevant personal ,educational , Work experience details ,attach resume and submit application form.
Click here for notification and Apply