Kenvue is currently recruiting for Manager, Global Case Processing |Pharmacovigilance (PV)

Manager, Global Case Processing-2407019070W

Description

 Kenvue is currently recruiting for:Manager, Global Case Processing

This position reports to AD Global Case Management and is based at Mumbai, India

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

Qualifications

What we are looking for

Qualifications

Education:

·       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

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