Job title: Manager, Pharmacovigilance Inspection & Audit Support (New Consumer Health Company)
Company: Johnson & Johnson
Job description: Johnson & Johnson is currently recruiting for a Manager, Pharmacovigilance inspection & Audit Support (New Consumer Health Company). This position may be located in Fort Washington, PA Skillman, NJ Livingston, Scotland or High Wycombe, England. Carin
Johnson & Johnson is currently recruiting for a Manager, Pharmacovigilance inspection & Audit Support (New Consumer Health Company). This position may be located in Fort Washington, PA Skillman, NJ Livingston, Scotland or High Wycombe, England. 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. Job Description: The Manager, Pharmacovigilance Inspection & Audit Support and Quality and Compliance (Q&C) Governance is responsible for oversight of Medical Safety Quality, compliance governance, and oversight forums. Additionally, the role is responsible for preparation, coordination, management, reporting, follow-up of Regulatory Authority (RA) inspections, and Marketing/Alliance Partner Pharmacovigilance audits of relevant functional groups. Keys for success in this role include the ability to develop partnerships with Regulatory Affairs and Local Operating Company colleagues of all levels and to influence without authority when issues arise. The individual must resolve sophisticated issues independently and establish when notification to senior management is appropriate. Roles and Responsibilities: This position will: Coordinate planning, conducting, and following up on action items derived from PV Q&C Governance Forums Manage PV inspection and audit support activities including, but not limited to: Audit and inspection management: coordinate scheduling, logistics, preparation, confirming Subject Matter Expert (SME) lists and interviewees, updating organization charts and overview presentations, and managing pre-audit requests for information Manage resources for unannounced RA inspections: prepare and maintain Master SME Lists, contact lists, organization charts, overview presentations, and information related to previous HA inspections Manage PV questionnaires, surveys, and queries from Marketing/Alliance Partners and Health Authorities Maintain Audit/Inspection mailbox Maintain audit and inspection master schedule Prepare and communicate audit/inspection related metrics and reports System support and content management Process management Ensuring that all incoming audit and inspection related communications are escalated to the appropriate business functions in a timely manner Confirming that responses to incoming audit and inspection related inquiries are complete and receive the appropriate internal review and are approved prior to submission Prioritizing audit and inspection-related activities based on urgency and risk Other duties as assigned include: Supporting the operational compliance and quality oversight functions as necessary Qualifications Position Requirements: Minimum of Bachelor’ 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 Experience with safety processing, clinical study safety reporting, PV, and medical information Knowledge of global PV laws and regulations Experience in participation, management, or conduct of audits/inspections Proficiency in Microsoft Excel and SharePoint Problem solProblem-solvinginterpret data & information, analyze, and make recommendations Preferred Requirements: 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 Experience developing and conducting presentations for different levels of management with the ability to tailor presentations to the appropriate level of detail At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families, and the communities in which we live and work. For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit www.careers.jnj.com. 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. Primary Location United States-Pennsylvania-Fort Washington-7050 Camp Hill Road Other Locations Asia Pacific-India-Maharashtra-Greater Mumbai, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, Europe/Middle East/Africa-United Kingdom-Scotland-Livingston, Asia Pacific-Philippines-National Capital-Manila, North America-United States-Pennsylvania-Horsham, United States-New Jersey-Skillman Organization Janssen Research & Development, LLC (6084) Job Function Regulatory Affairs Requisition ID 2206064891W
Expected salary:
Location: Mumbai, Maharashtra
Job date: Sun, 11 Sep 2022 22:42:43 GMT
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