Johnson & Johnson Careers
MANAGER- GLOBAL AGGREGATE REPORTING AND RISK MANAGEMENT
Requisition ID: 1905732304W
In India, Johnson & Johnson operates as a single legal entity and consists of the 3 strategic business units: Consumer Products, Pharmaceuticals and Medical Devices, which are independently managed and report into their respective Global business segments.
Sector Overview: The Consumer segment of Johnson & Johnson touches a billion lives around the world and works with the vision of 'Bringing science to the art of healthy living'. We offer some of the world’s most beloved Consumer Packaged Goods and Over-The-Counter medicine (OTC) which are endorsed by healthcare professionals around the world. In India, the company touches the lives of consumers through Baby Care, Women’s Health, Beauty, Oral & Wound Care and OTC. Some of our key brands include Johnson's® Baby, Stayfree®, Clean & Clear™, Band-Aid®. Listerine® and Benadryl®.
Position Title: MANAGER- GLOBAL AGGREGATE REPORTING AND RISK MANAGEMENT
Department Name / Franchise: Global Product Safety
Reports to (Title / Designation): Director or Associate Director, Global Aggregate Reporting and Risk Management (GARRM)
Role Overview: The manager supports the Associate Director and Director in all activities associated with the aggregate analysis and regulatory activities. She/he will be responsible for core safety deliverables including scheduled and unscheduled aggregate reports, Risk Management plans (RMPs) and Company Core Data Sheets (CCDS) and will serve as the report owner for assigned reports. The manager is an aggregate reporting expert and will have in-depth product knowledge to support daily activities including planning, conducting meetings, database searching, aggregate safety analysis and case level review, writing, project management/coordination of strategic safety documents, and oversight of deliverables produced by other team members. The manager provides subject matter expertise and technical guidance on functional requirements and enhancements to meet emerging global regulatory requirements and implementation of global aggregate reporting solutions and training, monitors compliance metrics and implements corrective and preventative actions to remediate non-conformance issues. She/he will partner with team members, stakeholders including Medical Safety Officers (MSOs), Qualified Person for Pharmacovigilance (QPPV) as appropriate, Global Case Management, Epidemiology, Regulatory Affairs, Clinical and Medical Affairs, Safety Data Analytics, Local Safety Officers (LSOs), and contracted vendor organizations.
- Ensure timely, quality reports/safety analyses related to core deliverables as appropriate:
- Collaborate with report physician, QPPV (where applicable) and other stakeholders on strategy development
- Provide oversight of staff involved in aggregate reporting
- Develop quality systems and procedures for the aggregate analysis and reporting of adverse effects related to Consumer products, to assure regulatory compliance with company standards and regulatory requirements
- Initiate/Conduct/Oversee searches of internal and external databases
- Perform management review of all vendor produced materials (e.g. draft reports and assessment responses); and/or lead aggregate safety analysis and case level review
- Author, contribute, and coordinate the preparation of core safety deliverables
- Prepares global aggregate reports for local authorities
- Ensure compliance (quality, procedures, regulations, consistency) and commitments (e.g., Pharmacovigilance Agreements (PVAs), assessment reports) are met, where applicable
- Partner with vendor to develop reports/deliverables
- Participate in cross-functional training of relevant stakeholders
- Act as product or process Subject Matter Expert (SME) during audits/inspections
- Daily management of vendor activities and responsibility for compliance with SOPs/WIs, global regulations/guidelines by either onsite or offshore resources
- Develops and coordinates processes for offshore vendor
- Performs training, onboarding, and oversight of offshore vendor
- Trains, self, employee, and contractors on the pharmacovigilance responsibilities prior to work engagements; updates training of self and others as required in compliance with schedules and regulations
- Department initiatives
- Participate or lead· department and/or cross-functional initiatives
- Contributes metrics and ensures reports’ accuracy and timelines are me
- Recognize potential issues and or safety issues and escalate appropriately per Company policy
- Ability to understand nature of adverse drug reactions and complex associations
- Insight and examples of application of management skills required to lead global, outsourced operations
- Advanced level working knowledge of safety databases to identify inefficiencies or the need for system enhancements High level of flexibility and ability to (re)prioritize work of oneself and others
- Attention to detail and ability to analyze data in broader context
- Ability to work across multiple functions and therapeutic areas
- Review regulatory assessor comments/requests and address as appropriate
- Manage vendor activities and resolves potential issues
- Education: Bachelor’s degree in life-sciences or health-care field or advanced degree (e.g., MS, MPH, PharmD, or PhD). Masters preferred.
- Experience: Overall 10+ years relevant experience. preferred with 3+ years of experience in Pharmacovigilance or related industry/domain.
A. Internal Applicants: If you wish to apply, please consider the following information from our Policy:
We require you to have spent at least 18 months in your current position, and in good standing. As our employee, you may apply for a position without informing current manager. However, when invited to interview, then, to the extent that this is consistent with local law or practice, you are required to notify your manager prior to the interview. This notification is reassured to promote development discussions between the managers and our employees.
If you want to refer external talent for this position, please review our Global Referral Policy and submit your referral through My Career Opportunities by following the appropriate process. (Applicable only for Internal postings)
B. External Applicants: Login to careers.jnj.com, search job matching you profile by location, keywords, requisition number.
Johnson & Johnson Private Limited (8080)