Manager, Central Pharmacovigilance HUB (1 of 2)
Location:
, New Jersey
Posted:
April 02, 2017
Reference:
000019GI/1-en-us

Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies is hiring a Manager, Central Pharmacovigilance HUB in Skillman NJ. In addition, we are open to candidates working remotely within the US or EMEA.  

 

Johnson & Johnson Family of Companies touches more than a billion people’s lives each day through our health care products and services, our corporate giving, and the volunteer efforts of our employees. The Johnson & Johnson Family of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and OTC products.


The Manager, Central Pharmacovigilance HUB, manages the process for ensuring that all Company-sponsored activities that generate, collect, utilize, or analyze data collected from health care professionals (HCPs), patients, consumers or caregivers or is generated from or by patient experiences with medicinal products meet the following requirements:

  • Activity is entered into the applicable tracking system that generates Pharmacovigilance System Master File (PSMF) listings
  • Pharmacovigilance language is present in contracts when a supplier conducts a non-interventional research related activity
  • Suppliers complete applicable Pharmacovigilance training as required by policy
  • Documented plan for collection, reporting and reconciliation of safety data
  • Review of activity by Pharmacovigilance reviewer to ensure activity is compliant with applicable safety requirements
  • Reconciliation was performed per defined procedures
  • Archiving and retention of relevant documents

 He / she will manage operational activities to ensure safety data is collected and analyzed by applicable medical safety group.  He / she will collaborate and coordinate activities with key functional partners to ensure adherence to internal policies and procedures.

Responsibilities:
  • Manage operational activities, including vendor oversight, to ensure safety data collected and analyzed by applicable medical safety group.
  • Manage the vendor safety data management training program for Company-sponsored activities that generate, collect, utilize, or analyze data collected from health care professionals (HCPs), patients, consumers or caregivers or is generated from or by patient experiences with medicinal products. 
  • Develop and implement process efficiencies and continuous improvements to decrease cycle time and improve quality.
  • Implement standard operating procedures, work instructions and training materials for Company-sponsored activities that generate, collect, utilize, or analyze data collected from health care professionals (HCPs), patients, consumers or caregivers or is generated from or by patient experiences with medicinal products.
  • Act as a business lead for internal audits and external inspections representing the pharmacovigilance process for Company-sponsored activities that generate, collect, utilize, or analyze data collected from health care professionals (HCPs), patients, consumers or caregivers or is generated from or by patient experiences with medicinal products
  • People management and development
  • Lead process improvements and drive change management initiatives to drive efficiency
  • Liaise with commercial organization and Local Safety Organization to ensure compliance objectives are met
  • Balance interests of stakeholders to achieve performance and quality
  • Overall accountability for implementation of process that meet compliance objectives


Qualifications
  • A minimum of a Bachelor Degree in health related field or other related scientific degree/qualification.
  • Minimum of 10 years’ pharma, medical device, or consumer experience is required
  • 3 years in a management role is required
  • Management of a remote workforce and external vendors is preferred
  • Individual Case Safety Report operational experience is preferred.
  • Excellent communication skills, both written and verbal as well as demonstrable relationship building skills
  • Business orientated and have worked closely with commercial partners with the ability to influence others
  • Impeccable ethics, transparency in addition to the managerial courage 


Primary Location
United States-New Jersey-Skillman
Other Locations
Europe/Middle East/Africa, North America-United States
Organization
J & J Consumer Inc. (6101)
Job Function
Pharmacovigilance
Requisition ID
000019GI

A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.

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