Associate Manager, PV Medical Safety Compliance Oversight

Kenvue is currently recruiting for:

Associate Manager, PV Medical Safety Compliance Oversight

This position reports into Associate Director of Medical Safety and is based at Greater Mumbai.

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 up with 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

The position is responsible for:

• Day-to-day oversight of investigations of Late Health Authority ICSR submissions, 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.

• Responsibilities also include 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 Medical Safety Performance and Compliance.

• Oversees investigations and trending of Late Health Authority ICSR submissions and the timely exchange of ICSRs with Alliance Partner

• Oversees ESI / SSI global tracking process and monitors compliance of ESI / SSI submissions to global Health Authorities.

• Generation, quality control and approval of metrics related to PV compliance as well as other key OCMS compliance metrics.

• Collaborate with internal and external partners and stakeholders to ensure metrics are reported and/or reconciled in a timely manner. Escalate non-compliance to management.

• Develop and update controlled documents.

• Perform User Acceptance Testing for systems used to monitor compliance.

• Other duties as assigned.

What We Are Looking For

• Minimum of Bachelor’s Degree in relevant discipline (Business, Science, Medical, Operations, etc.) with 8 years of pharmaceutical industry experience or 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 GxP requirements and experience with safety processing, clinical study safety reporting, PV, and medical information.

• Knowledge of global PV laws and regulations.

• 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.

• Experience in participation, management, or conducting audits/inspections.

• Project Management experience with organizing actions and managing team activities is preferred.

• Proficiency in Microsoft Excel and SharePoint.

• 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 preferred.

What’s In It For You

• Competitive Benefit Package

• Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!

• Learning & Development Opportunities

• Employee Resource Groups

• This list could vary based on location/region

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.