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 by 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. For more information, click here.
What you will do
The Senior (Sr.) Scientist, Global PV Aggregate Reporting and Risk Management (GARRM) will be responsible for core safety deliverables including scheduled aggregate safety reports, Risk Management Plans (RMPs) and Company Core Data Sheets (CCDS) and will serve as the report owner for assigned reports within Medical Safety for Kenvue products. The Sr. Scientist 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.
She/He will partner with team members, stakeholders including Global Risk Assessment and Safety Physicians (GRASPs), Qualified Person for Pharmacovigilance (QPPV), Global Product Risk Management (GPRM), PV Policy, Signal Detection and Management (SDM), Global Literature Review (GLR), Global Case Management (GCM), Epidemiology, Regulatory Affairs, Clinical, Medical Affairs, Global Pharmacovigilance System Operations (GPSO), Local Pharmacovigilance (LPV), Strategic Planning and Oversight (SPO), and third-party vendor organizations.
Key Responsibilities
Ensure timely, quality reports/safety analyses related to core deliverables as appropriate: Collaborate with GRASP, QPPV (where applicable), and other stakeholders on strategy development Provide oversight of staff involved in aggregate reporting 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 Prepare 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 Develop and maintain global pharmacovigilance aggregate reporting processes and procedures in compliance with regulatory requirements. Collaborate with cross-functional teams to ensure timely and accurate data collection and analysis for aggregate reporting. Develop and maintain systems, tools and processes for drug safety operations. Participate and/or lead cross-functional training of relevant stakeholders and colleagues. 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. Perform training, onboarding, and oversight of offshore vendor. Participate or lead department and/or cross-functional initiatives. Contribute metrics and ensures quality, compliance, and timeliness of aggregate safety reports.
What we are looking for
Required Qualifications
Bachelor’s degree required (health/life sciences field) ≥3 years of experience in the pharmaceutical or related industry with ≥2 years of experience in Pharmacovigilance Proven experience working in matrix environment and cross-functional teams Comprehensive clinical/medical writing experience Strong English verbal and written communication skills Strong knowledge of global pharmacovigilance regulations and guidelines (i.e., ICH, GVP, etc.). Ability to work collaboratively with cross-functional teams. Strong analytical and problem-solving skills. High level of flexibility and ability to (re)prioritize work of oneself and others.
Desired Qualifications
Advanced degree (e.g., MS, MPH, MSN, PharmD, RPh, PhD, etc.) preferred Strong leadership and presentation skills. Experience in developing and implementing drug safety policies and operating procedures. Ability to work in a fast-paced environment and manage multiple projects simultaneously. SME with in-depth product knowledge of assigned products; knowledge and hand-on experience in aggregate reports writing and compliance management. In-depth working knowledge of AE safety databases to identify system enhancements and efficiencies.
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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 by 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. For more information, click here.
What you will do
The Senior (Sr.) Scientist, Global PV Aggregate Reporting and Risk Management (GARRM) will be responsible for core safety deliverables including scheduled aggregate safety reports, Risk Management Plans (RMPs) and Company Core Data Sheets (CCDS) and will serve as the report owner for assigned reports within Medical Safety for Kenvue products. The Sr. Scientist 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.
She/He will partner with team members, stakeholders including Global Risk Assessment and Safety Physicians (GRASPs), Qualified Person for Pharmacovigilance (QPPV), Global Product Risk Management (GPRM), PV Policy, Signal Detection and Management (SDM), Global Literature Review (GLR), Global Case Management (GCM), Epidemiology, Regulatory Affairs, Clinical, Medical Affairs, Global Pharmacovigilance System Operations (GPSO), Local Pharmacovigilance (LPV), Strategic Planning and Oversight (SPO), and third-party vendor organizations.
Key Responsibilities
Ensure timely, quality reports/safety analyses related to core deliverables as appropriate: Collaborate with GRASP, QPPV (where applicable), and other stakeholders on strategy development Provide oversight of staff involved in aggregate reporting 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 Prepare 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 Develop and maintain global pharmacovigilance aggregate reporting processes and procedures in compliance with regulatory requirements. Collaborate with cross-functional teams to ensure timely and accurate data collection and analysis for aggregate reporting. Develop and maintain systems, tools and processes for drug safety operations. Participate and/or lead cross-functional training of relevant stakeholders and colleagues. 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. Perform training, onboarding, and oversight of offshore vendor. Participate or lead department and/or cross-functional initiatives. Contribute metrics and ensures quality, compliance, and timeliness of aggregate safety reports.
What we are looking for
Required Qualifications
Bachelor’s degree required (health/life sciences field) ≥3 years of experience in the pharmaceutical or related industry with ≥2 years of experience in Pharmacovigilance Proven experience working in matrix environment and cross-functional teams Comprehensive clinical/medical writing experience Strong English verbal and written communication skills Strong knowledge of global pharmacovigilance regulations and guidelines (i.e., ICH, GVP, etc.). Ability to work collaboratively with cross-functional teams. Strong analytical and problem-solving skills. High level of flexibility and ability to (re)prioritize work of oneself and others.
Desired Qualifications
Advanced degree (e.g., MS, MPH, MSN, PharmD, RPh, PhD, etc.) preferred Strong leadership and presentation skills. Experience in developing and implementing drug safety policies and operating procedures. Ability to work in a fast-paced environment and manage multiple projects simultaneously. SME with in-depth product knowledge of assigned products; knowledge and hand-on experience in aggregate reports writing and compliance management. In-depth working knowledge of AE safety databases to identify system enhancements and efficiencies.
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