Kenvue is currently recruiting for a Senior Specialist Global Pharmacovigilance System OperationsWhat we do 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 Who We Are Our global team is 22 000 brilliant people with a workplace culture where every voice matters and every contribution is appreciated We are passionate about insights innovation and committed to delivering the best products to our customers With expertise and empathy being a Kenvuer means having the power to impact 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 Role reports to AD Safety Analytics and SystemsLocation Asia Pacific India Maharashtra Greater MumbaiWork Location HybridWhat you will do Travel 10 Pay If compliant with country s laws What you will do The Senior Specialist Global PV System Operations is responsible for supporting the Associate Director Safety Analytics and Systems in the maintenance of Pharmacovigilance PV System Operations and partner with Information Technology internal and vendor teams 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 system activities performed by vendor including but not limited to Argus analytics set-up of Reporting rules RRs product additions protocol configurations and MedDRA system upgrades to enable safety reporting in compliance with local regulatory requirements and or third-party agreement requirements Supervises activities performed by vendors by monitoring daily metrics including training metrics Plays a key role in team meetings and daily liaison with the vendor team to identify and resolve support desk issues Provide guidance and support to clarify procedures e g training to ensure compliance relating to support of reporting rules for Business Partners and Health Authorities Contribute and Participate in Change Control process User Acceptance Testing UAT activities for vendor supported systems and Kenvue supported systems Liaise with staff in GMSO Global Medical Safety Operations function 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 Assist Manager Associate Director in 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 system operational activities associated with Global PV Systems Operations activities or other scopes 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 Oversee vendor training and development activities Maintain 100 compliance in all assigned training 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 Previous industry experience with system implementation 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 Previous Computer Systems Business Validation experience Previous experience in Oracle ARGUS Safety including reporting rules and company product dictionary What s in it for you Competitive Benefit Package Paid Company Holidays Paid Vacation Volunteer Time More Learning Development Opportunities Kenvuer Impact Networks 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 Prospect Employer All qualified applicants will receive consideration for employment based on merit 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 If you are an individual with a disability please check our Disability Assistance page for information on how to request an accommodation

📌 Senior Specialist Global Pharmacovigilance System Operations (Maharashtra)
🏢 Kenvue
📍 Maharashtra