Associate Director, Product Vigilance Physician (AD PVP)
Location:
Fort Washington , Pennsylvania
Posted:
April 02, 2017
Reference:
5667170109/1-en-us

Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies is hiring an Associate Director, Product Vigilance Physician (AD PVP) in Fort Washington, PA or Skillman NJ.

 

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 Associate Director, PV Physician (AD PVP) for Consumer products is the medical expert and technical leader of other PV Physicians (PVP) in the medical evaluation and regulatory reporting of adverse event reports for the products of the Johnson & Johnson Family of Consumer Companies. The AD, PVP is accountable to establish and oversee instruments for global policy and guidance for medical review, case interpretation and decision making to ensure compliance with regulatory reporting requirements worldwide and departmental Standard Operating Procedures (SOP).

 
Responsibilities:
 
  • Develops quality systems and procedures for the triage, medical review and evaluation of adverse effects related to medicines, cosmetics, and medical devices, to assure regulatory compliance with company standards and regulatory requirements
  • Provides subject matter expertise and technical guidance on medical assessment enhancements to meet emerging global regulatory requirements and implementation of a global adverse event case management solution; monitors compliance metrics; and, implements corrective and preventative actions to remediate non-conformance issues
  • Leads cross-functional governance teams to ensure strategic alignment of priorities among key business stakeholders; manages vendor activities to ensure deliverables are met as defined in the supplier agreement; monitors key performance indicators to identify and implement process efficiencies and quality improvements; and, coordinates staff training and controlled document development to ensure consistent, standardized processes are in place.
  • Ensures consistency in global processes by establishing guidelines for clear procedures and overseeing the development of appropriate measures, standard operating procedures and other work practices.
  • Performs as lead subject matter expert (SME), and manages participation of PV physician staff in quality and compliance audits and inspections.
  • Provides effective responses to internal and external audits of medical case review activities and the corrective actions arising from these audits.
  • Delivers medical assessments for individual case safety reports from clinical trials and post-marketed products by managing multidisciplinary project teams including NA, LATAM, EMEA and/or AP based company or outsourced operations
  • Contributes metrics to quarterly annual reports and coordinates accuracy and timeliness. Ensures that reporting timelines are met and reported internally
  • Prepares global individual case safety reports and submissions to local authorities
  • Controls and assures the quality of the scientific and material content of any documents, files, or other materials sent to regulatory agencies
  • Independently identifies information impacting product safety of new and marketed products and escalates findings to management following company procedures
  • Trains self, employees and contractors on their PV responsibilities prior to work engagements; updates training of self and others as required on an annual basis in compliance with schedules and regulations


Qualifications
  • US Medical Doctor (MD) degree or worldwide equivalent from an accredited, ECFMG/USMLE eligible institution with sound knowledge of general medicine is required
  • A minimum of eight (8) years of direct or related professional experience is required
  • A minimum of four (4) years of technical PV subject matter expertise is preferred
  • Expert level knowledge and hands-on experience in individual case safety report medical evaluation, coding, documentation, and submission to health authorities is preferred
  • Advanced level understanding of international pharmacovigilance regulations is preferred
  • Demonstrated success in global operations, team and people management; insight and examples of application of management skills required to lead global, outsourced operations is preferred
  • Excellent written and verbal communication skills in English is required
  • Demonstrated ability to create or improve medical case review and reporting operations is preferred
  • Experience with Consumer Product safety, medical affairs, clinical research, or regulatory affairs is preferred
  • Medical specialization in internal medicine, pediatrics, or general/family practice is preferred


Primary Location
United States-Pennsylvania-Fort Washington
Other Locations
North America-United States-New Jersey-Skillman
Organization
J & J Consumer Inc. (6101)
Job Function
Drug & Product Safety Science
Requisition ID
5667170109

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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