At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a balanced mind, body and environment within reach of everyone, everywhere.
Every single 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.
We are recruiting for a Manager, Global Aggregate Reporting and Risk Management, located in High Wycombe, UK.
The manager supports the Associate Director, GARRM 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 authority 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 mentorship on functional requirements and improvements 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. You will partner with team members, 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.
- Providing oversight and quality review to all safety reports within the Consumer stronghold (i.e., therapeutic area) to ensure they are high quality aligned within timelines and applicable regulations.
- Initiating/conducting/overseeing searches of internal and external databases.
- Collaborate with our key partners on process improvements and streamlining efforts.
- Ensure compliance (quality, procedures, regulations, consistency) and commitments (e.g., Pharmacovigilance Agreements (PVAs), assessment reports) are met, where applicable.
- Managing vendor activities and responsibility for compliance with SOPs/WIs, global regulations/guidelines by either onsite or offshore resources.
- Developing 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.
- Acting as product or process Subject Matter Expert (SME) during audits/inspections.
- Participating in or lead departmental, cross-functional and/or cross-sector initiatives.
Do you have for following qualifications, experience and skills ?
- Bachelor degree in life-sciences or health-care field or advanced degree (e.g., MS, MPH, PharmD, or PhD),
- Experience working in a matrix environment and with cross-functional teams, including the ability to independently lead projects and other initiatives.
- Comprehensive clinical/medical writing experience.
- Experience working with global safety databases, including case management and comprehensive data analysis.
- Working knowledge of applicable global and regional regulatory requirements (i.e., ICH guidelines, GVP, etc.)
- Third-party vendor selection and oversight.
- Inspection and audit support, including readiness activities.
- CAPA management, including root-cause analysis and effectiveness checks.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
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
United Kingdom-England-High Wycombe-
J&J Consumer Services EMAE., Ltd (8675)