Johnson & Johnson Released Job Openings On 04/11/2022.Caring for the world, one person at a time, inspires and unites the people of Johnson & Johnson..Application form link provided at the end of post.
Johnson & Johnson Recruiting 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 for Associate Manager, Pharmacovigilance Quality & Compliance Position.Complete Details for the Associate Manager, Pharmacovigilance Quality & Compliance as follows.
Important Details :
- Location : Mumbai
- No of Vacancies:NA
- Details of Salary: Not Disclosed by Recruiter
- Opening date for online Application: 04/11/2022
- Mode of application :Online
- How To Apply: At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps
Job Description/Skills Required
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 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