Job title: Manager- Pharmacovigilance CAPA

Company: Johnson & Johnson

Job description: 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 creative ideas, products and services to advance the health and well-being of people. E

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 creative ideas, products and services to advance the health and well-being of people. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity. Janssen India, the pharmaceutical division of Johnson & Johnson India, is dedicated to addressing and solving some of the most important unmet medical needs of our time in India, in oncology, immunology, neuroscience and analgesia, dermatology, infectious diseases and metabolic diseases. Driven by a strong dedication to the health and well-being of patients, Janssen India brings innovative products, services and solutions to people throughout the world. Janssen recognizes the impact of serious conditions on people’s lives, and aims to empower people through disease awareness, education and access to quality care in six therapeutic areas. POSITION SUMMARY: In support of End-to-End PV (Pharmacovigilance) CAPA Management process across segments, the PV CAPA Manager will be responsible to provide CAPA process oversight of PV Deviations and CAPAs associated with audit and inspection findings across the Consumer and Pharm sectors. The PV CAPA Manager will monitor investigations and approvals to ensure that all required information is captured and documented with relation to PV-related CAPAs. The PV CAPA Manager will have responsibility for ensuring the investigation and CAPA owners are progressing to plan by monitoring status and providing feedback and comments to direct progress during investigation and root cause analysis phases, and during preparation of Corrective/Preventative action plans and effectiveness monitoring plans. The PV CAPA Manager will be responsible for proactively driving process improvements in the CAPA management process and is a subject matter expert in CAPA management process and system. Principal responsibilities: Oversees the kickoff and execution of activities required for PV CAPA management in coordination with QA auditor or BRQC Regulatory Compliance lead as applicable. Liaise with business stakeholders through CAPA Lifecycle management. Reviews findings and makes recommendations for Corrective Action plan to ensure robust CAPA that eliminates recurrence of noted issues. Tracks CAPA’s through completion and effectiveness monitoring, including updates to senior management. Keeps holistic view of common findings per PV audits, HA inspections and functional observations. Communicate, coordinate, and escalate as needed all activities associated with completion of the investigation or CAPA as per committed timeline. Track progress against schedule. Manage multiple concurrent activities and stakeholders. Attend, participate and/or facilitate PV CAPA review meetings Decision-making and problem-solving: Ability to utilize appropriate initiative and autonomy in achieving objectives works independently. Requires management skills for multidisciplinary interactions and coordination. Facilitates resolution of complex issues and must manage stakeholders at varying levels of management across multiple organizations. Requires a level of skill in managing difficult situations constructively. Excellent communication and writing skills demonstrated by the ability to write executive summaries and ad hoc reports promptly and clearly as well as compile and present data to other professionals. Requires strong analytical skills to examine data and perform analysis Requires autonomy in decision-making to approve the appropriateness, effectiveness, quality and compliance of documented robust investigation, root cause analysis and corrective/preventative action plans. The position reports directly to the Director, PV CAPA Management. Location: Remote Qualifications EDUCATION & EXPERIENCE REQUIREMENTS: Describe the minimum knowledge, skill and ability requirements for the position. Include any degrees or certifications which are required and/or desirable. Director, PV CAPA Management – interfaces and informs as needed to discuss issues. CSA CAPA Management team members – interfaces daily as needed to manage workload interfaces weekly in team meetings. Senior Management in Global Medical organization, Bioresearch Quality & Compliance, Regulatory Affairs, Medical Affairs, and other business functions involved in owning and delivering CAPA commitments. Interfaces as needed to address identified issues and provide guidance on established processes. J&J partners – interfaces as needed to address cross-company and cross-departmental issues. Related experience: 6 to 8 years Are you ready to impact the world Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. This description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Primary Location India-Maharashtra-Greater Mumbai- Organization Johnson & Johnson Private Limited (8080) Job Function Quality Requisition ID 2206044572W

Expected salary:

Location: Mumbai, Maharashtra

Job date: Tue, 07 Jun 2022 22:21:19 GMT

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