Manager, Global Pharmacovigilance System Operations
1 week ago
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For more information, click here . Role reports to: AssociateDirector, Global PV System Operations Location: India Travel %: 10% What you will do The Manager, Global PV System Operations is responsible for supporting the Director, GPSO in the maintenance of Pharmacovigilance (PV) System Operations and partner with Information Technology (internal and vendor teams) and Safety Science and Analytics (SSA) on the implementation of new systems, maintenance of existing systems, applicable interfaces and providing support to users for the vendor supported systems. Key Responsibilities * Responsible for oversight of vendor staff including operational and ticketing management activities in Medical Safety Support Desk ensuring that vendor is meeting service level agreements.
Manages vendor relationship and resolves potential issues * Oversee system activities including but not limited to Argus analytics, set - up of distribution rules (DRs), product additions, protocol configurations, and MedDRA/system upgrades to enable safety reporting in compliance with local regulatory requirements and/or third-party agreement requirements * Assist Associate Director, GPSO in implementation of new PV systems and major systems upgrades including change process to ensure all PV systems and processes are maintained in compliance to current internal and global regulatory regulations * Manage the change process/user acceptance testing and ensure timely and relevant communication to appropriate groups * Liaise with staff in GSO (Global Safety Operations) fu nction and other external functions as appropriate to facilitate compliant, timely and efficient case processing and reporting activities including electronic (E2B) or manual reporting of Individual Case Safety Reports (ICSRs) to Regulatory Authorities, Business Partners, Ethics Committees and investigators in accordance with Worldwide Safety Regulations, corporate and regulatory guidance documents, corporate policies, and/or third-party agreements * Monitor activities of individuals responsible for distribution rules set up to enable electronic and manual reporting of ICSRs to Regulatory Authorities and/or Business Partners * Management of staff, as identified (including performance management, career development planning), is aligned with strategic Medical Safety goals and objectives * Lead CAPA management and / or provide oversight to investigations, assigned CAPAs, Task Actions, Effectiveness Checks and associated documentation ensuring documentation accuracy, compliance with completion timelines, and inspection ready state of all documentation * Participate in audits and inspections regarding operational activities associated with Global PV Systems Operations activities or other scope as identified * Accountable for the development and implementation of Standard Operating Procedures (SOPs)/Work Instructions (WIs) relating to distribution rules set up and electronic reporting of safety information * E nsure 100% c ompliance in all assigned training activities for vendor and maintain knowledge of department policies and procedures What we are looking for Required Qualifications * BA or BSc degree in health-related field or other related scientific degree/qualification * Broad knowledge of pharmacovigilance with experience in inbound case receipt, regulatory reporting, case processing and other areas of PV * Previous industry experience with a focus on consumer safety related areas.
Typically demonstrated by a minimum of 5-8 years industry experience and 3 years in management role * Previous industry experience with system development and implementation * Previous Computer Systems Business Validation experience * Project management experience on complex multi-stakeholder projects * Ability to independently make decisions and understand complexities of Kenvue products and Adverse Event categories in order to properly establish accurate queries.
Problem solving abilities to handle electronic and distribution rules issues and escalate when appropriate * Excellent verbal, written and presentation skills. Desired Qualifications Experience in leading change on at least one global project and thrive in a global matrix environment. What's in it for you * Competitive Total Rewards Package* * Paid Company Holidays, Paid Vacation, Volunteer Time & 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 based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, or any other legally protected characteristic, and will not be discriminated against on the basis of disability.
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mumbai, India Johnson & Johnson Consumer Inc Full timeDescription Kenvue is currently recruiting for: Manager, Global PV System Operations This position reports to Associate Director, Global PV System Operations (GPSO) and is based in India. 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...
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