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Job Details



Pharmacovigilance Project Managers  RTP, NC  Posted: 4/18/2022
Job Description

Job ID#:

7062

Positions Available:

2



Alphanumeric is seeking Pharmacovigilance Project Managers to work for one of the largest Pharmaceutical companies in the World.  Based in the Research Triangle Park, NC (Raleigh / Durham, NC) - Remote

This is a critical role in oversight and management of the vendor involved in pharmacovigilance case processing and reporting of Consumer Healthcare (CH) Human Safety Information (HSI) to Global Health Authorities.  

Responsibilities
  • Work within a global team to provide oversight of supplier delivery of PV services within a defined scope of activities aligned with specific supplier processes and deliverables.
  • Maintain alignment of supplier delivery with company strategy, adhering to the third-party engagement framework and  implementing third party oversight
  • Supporting regulatory inspections, investigating/resolving issues and escalations and advancing methodology/process improvement initiatives.
  • Ensure supplier delivery of PV services within a defined scope of accountability meet agreed upon metrics, milestones, and KPIs
  • Aligns PV supplier with business strategy within respective function(s) and liaises across the PV global networks managing internal stakeholders
  • Accountable to build external relationships with supplier personnel to ensure successful delivery of outsourced work
  • Works across a matrix environment to drive high quality delivery of PV activities that comply with internal standards and external regulatory requirements
  • Contributes to advancement of the broader CH PV business strategy and implementation of new initiatives in the functional team
  • Identifies and implements performance improvement initiatives with service supplier
  • Where problems or issues are identified, conducts investigation into root causes and manages corrective/preventative actions



 
Job Requirements

 

Requirements

  • BSc/BA in a scientific or medically related field, plus experience in the pharmaceutical industry in pharmacovigilance, clinical development, or medical information. Equivalent work experience considered.
  • In depth knowledge of GCP and GVP requirements, clinical safety documentation and reporting of adverse events with a general understanding of world-wide requirements for PV.

Preferred

  • Experience with Consumer Healthcare products
  • Direct experience working with outsourced providers
  • Excellent oral and written communication skills
  • Experience with PV Case Management
  • Experience in change management within Central Safety and Local Operating Companies to drive forward new initiatives

This position requires that all workers be fully vaccinated against COVID-19 and proof of vaccination will be required. Considerations will be made for those seeking Medical Exemption under ADA or Religious exemption under Title VII

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