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Role reports to：
AD Safety Analytics and Systems位置：
Asia Pacific, India, Maharashtra, Greater Mumbai工作地點：
混合你會做什麼
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 Opportunity 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.
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