Job Description

DescriptionKenvue is currently recruiting for:Manager, Global Case ProcessingThis position reports to AD Global Case Management and is based at Mumbai, IndiaWho we areAt 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\xc2\xae Brand Adhesive Bandages that you already know and love. Science is our passion; care is our talent. Our global team is made up of ~ 22,000 diverse and brilliant people, 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 the 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 doThis position supports the operational and system management of case receipt, case processing, and safety reporting functions and represents OCMS in end-to-end case management activities both globally and locally. Also providing functional oversight of case management activities performed at contracted vendor organizations. Collaborating with staff in OCMS, across various functions within the Consumer Health business as well as across other sectors to facilitate compliant, timely, and efficient end to end case management.
Key Responsibilities:

• Responsible for functional oversight of vendor staff and local safety units involved in case receipt, case processing, and safety reporting. In addition to managing vendor relationship and resolving potential issues

• Expertise in operational activities including case processing. Providing subject matter expertise in pharmacovigilance (PV) and global/local AE regulatory reporting requirements

• Identifies and implements process efficiencies and continuous quality improvements to support business objective of cost-efficient sustainable and scalable end to end case management solutions

• Develop standard operating procedures, work instructions and training to support case management activities; ensuring vendor is adequately trained

• Supports the Director in internal audits and external inspections and develops corrective and preventative actions to address non-conformances

• Participates in cross-functional governance teams to ensure alignment of priorities among key business partners

• Performs other related duties as the need arises

What we are looking forQualificationsEducation:

• A minimum of Bachelor\'s degree in life sciences or health-care field with 5-8 years experience in Pharmacovigilance OR

• Advanced degree (e.g., MS, MPH, PharmD, or PhD) with 5 years of experience in Pharmacovigilance or related activities industry activities preferred OR

• Advanced degree with completion of a 2-year Pharmacovigilance fellowship.

Experience and Skills:Required:

• Demonstrated experience working in a matrix environment and cross-functional teams

• Practical knowledge of global and local regulatory pharmacovigilance requirements

• Understanding of medical terminology and ability to summarize medical information

• Ability to view the "big picture" and understand impact of decision taken within the team or function

Preferred:

• Working knowledge of safety databases to identify system enhancements and efficiencies including MedDRA and product dictionaries and version updates

• Experience working on CAPAs is strongly preferred

• Experience authoring and editing controlled documents (e.g., SOPs) is strongly preferred

• Experience overseeing vendors and local safety units is strongly preferred

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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