Manager Pv Compliance

Description

**Who We Are**

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Our global team is made by 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage - and have brilliant opportunities waiting for you Join us in shaping our future-and yours.

**What you will do**

Primarily responsible for the operational aspects of PV Medical Safety Compliance which includes oversight of Individual Case Safety Report (ICSR), Aggregate Report and ESI/SSI submission timeliness to Health Authorities, monitoring the timely exchange of ICSRs with Alliance Partners and monitoring inbound ICSR performance from multiple sources.
- Responsibilities also includes 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 Medical Safety Compliance 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 complex issues related to day-to-day activities independently and to determine when to escalate issues to senior management. Responsible for oversight of vendor resources performing services on behalf of Medical Safety Performance and Compliance.

**Responsibilities**:

- Oversees the following operational aspects of PV Medical Safety Compliance
- Investigations and trending of Late Health Authority ICSR submissions
- Timely exchange of ICSRs with Alliance Partners
- ESI/SSI global tracking process and monitors compliance of ESI / SSI submissions to global Health Authorities
- Generation, quality control and approval of PV compliance metrics and vendor key performance indicators
- Collaboration with internal and external partners and stakeholders to ensure business needs are met
- Provides compliance status update in relevant fora and escalate non-compliance to management
- Develops and updates controlled documents
- Makes decisions about day-to-day activities relating to Late Health Authority ICSR submissions, monitoring the timely exchange of ICSRs with Alliance Partners, Aggregate Report and ESI / SSI tracking and Health Authority submission compliance monitoring
- Accountable for prioritizing and ensuring deliverables are completed on time and are accurate and consistent. Follows documented procedures for late case investigation, trending, and metrics generation. Consults with Head of Medical Safety Performance and Compliance for complex issues and changes to processes and procedures
- Works independently to resolve routine issues and questions. Raises issues to Associate Director Medical Safety Performance and Compliance when they cannot be resolved to stakeholder / customer satisfaction or when timelines are in jeopardy

**Qualifications**:
**What we are looking for**

**Education and Experience**:

- A minimum of a Bachelor's Degree in a relevant discipline (Business, Science, Medical, Operations, etc.) with 10 years of pharmaceutical industry experience or an advanced academic degree with 8 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 PowerPoint
- 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 pres