Associate Director, Global Pharmacovigilance Aggregate Reports (PVAR)
Location:
Fort Washington , Pennsylvania
Posted:
April 02, 2017
Reference:
5785170117/2-en-us

Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies is hiring an Associate Director, Global Pharmacovigilance Aggregate Reports (PVAR) in Skillman, New Jersey or Fort Washington Pennsylvania.


Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. develops and markets baby care, wound care and skin care products that address the needs of consumers and health care professionals and incorporate the latest innovations. The portfolio includes heritage brands JOHNSON’S® Baby and BAND-AID® Brand, as well as leading skin care brands such as AVEENO® and CLEAN & CLEAR®


The Associate Director, Global Pharmacovigilance Aggregate Reports (PVAR) will be responsible for the day-to-day management and oversight of PVAR organization.  She/He will oversee compliance, quality, procedures, regulations, timeliness, and consistency of aggregate reports for Johnson& Johnson Consumer products. She/He will be responsible for the oversight of end-to-end off-shore vendor operations.  She/He has proven ability to provide technical as well as managerial leadership to a global staff of employees, contractors and vendors.


As a company expert on aggregate safety reports, the Associate Director PVAR leads cross-functional teams to develop and promote best practices, processes, identify new tools, and develop new policies to:

  • Promote consistent aggregate reports excellence,
  • Ensure safe and appropriate use of our products, and
  • Monitor performance trends and drive continue process improvements related to aggregate reports
 
Responsibilities:
  • Manage (direct, train, motivate, evaluate) to produce deliverables in compliance with current employment guidelines and corporate policies. This includes:
  • Daily management of staff activities and responsibility for compliance with SOPs, global regulations/guidelines, corporate policies and timelines.
  • Management of vendor activities including responsibility for quality and compliance with SOPs for the vendor staff
  • Manage resource needs and resource allocation based on workload.
  • Grow and develop talent.
  • Monitor performance trends and drive continue process improvements related to aggregate reports.
  • Develop, implement and support policies, standard operating procedures (SOPs), tools, etc., pertaining to aggregate safety reports
  • Build working partnerships and relationships with cross-functional groups within and outside OCMS including MSOs, SSRM, Regulatory, Clinical and others.
  • Support PV Operations, PV audits and inspections 


Qualifications
  • A minimum of a bachelor degree is required
  • A minimum of 5 years of pharmaceutical industry experience is required
  • A minimum of 3 years of experience in pharmacovigilance is preferred
  • Working knowledge of medical concepts and familiarity with safety activities in drug development and post marketing and global safety health authority requirements is required.
  • Attention to detail along with strong scientific, analytical and conceptual skills
  • Ability to understand complex medical-scientific data from a broad range of disciplines is required
  • Understand aspects and methods for data analysis, interpretation and presentation.
  • Ability to effectively interact with external stakeholders, including business partners
  • Knowledge of global regulatory framework for aggregate safety reports is required.
  • Experience in developing aggregate safety reports (e.g., PBRER/PSUR, PADER) is preferred.
  • Excellent verbal and written communication skills
  • Ability to plan work to meet deadlines and effectively handle multiple priorities
  • Proficiency in Microsoft Word, Excel, and PowerPoint is preferred 

Primary Location
United States-New Jersey-Skillman
Other Locations
North America-United States-Pennsylvania-Fort Washington
Organization
J & J Consumer Inc. (6101)
Job Function
Pharmacovigilance
Requisition ID
5785170117

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