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Manager, Global PV Aggregate Reporting
2 months ago
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 . Role reports to: Associate Director, Global PV Aggregate Reporting and Risk Management Location: Mumbai or Pune, India Travel %: 10 What you will do The Manager, Global Aggregate Reporting and Risk Management (GARRM) will be responsible for core safety deliverables including scheduled aggregate 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 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 Global Risk Assessment and Safety Physicians (GRASPs), Qualified Person for Pharmacovigilance (QPPV), Product Vigilance and Safety System Oversight, Signal Detection and Management (SDM), Global Case Management (GCM), Epidemiology, Regulatory Affairs, Clinical, Medical Affairs, Safety Science & Analytics (SSA), Local Pharmacovigilance (LPV), and contracted vendor organizations. Key Responsibilities * Ensure timely, quality reports/safety analyses related to core deliverables as appropriate: o Collaborate with GRASP, QPPV (where applicable), and other stakeholders on strategy development o Provide oversight of staff involved in aggregate reporting o 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 o Initiate/Conduct/Oversee searches of internal and external databases o 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 o Author, contribute, and coordinate the preparation of core safety deliverables o Prepares global aggregate reports for local authorities o Ensure compliance (quality, procedures, regulations, consistency) and commitments (e.g., Pharmacovigilance Agreements (PVAs), assessment reports) are met, where applicable o Partner with vendor to develop reports/deliverables * Develop and maintain global pharmacovigilance aggregate reporting processes and procedures in compliance with regulatory requirements * Lead and manage a team of pharmacovigilance professionals to ensure timely and accurate submission of aggregate reports * Collaborate with cross-functional teams to ensure timely and accurate data collection and analysis for aggregate reporting * Stay up-to-date with regulatory changes and industry trends related to pharmacovigilance aggregate reporting and implement necessary changes to processes and procedures * 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 * Performs training, onboarding, and oversight of offshore vendor * Participate or lead department and/or cross-functional initiatives * Contributes 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) * > 5 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. 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 What's in it for you * Competitive Benefit Package* * Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More * Learning & Development Opportunities * Employee Resource Groups * This list could vary based on location/region *Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits.
Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process. Kenvue is proud to be an 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.
