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Director, Pharmacovigilance/Drug Safety (Marketed Products) - NC Pharm

Company: Frankel Staffing Partners
Location: Raleigh
Posted on: February 22, 2021

Job Description:

Our client, a successful and expanding specialty pharmaceutical company headquartered in Research Triangle Park, NC, is actively recruiting for a highly skilled and knowledgeable candidate to drive all Pharmacovigilance and Drug Safety efforts, with near-term focus on marketed products.
This is an important and impactful position and Company will pay outstanding wage to attract the right candidate. While NC candidates are preferred, client is open to remote candidates who can readily travel to Raleigh (East Coast).
Key Things to Note:-- This Company has an impressive portfolio of marketed products, a rich and expanding pipeline and aggressive plans for growth. This PV/Safety Director will focus on marketed products but may also get involved with development products in the future. -- Position will report to the CSO and oversee all PV/Safety operations, much of which is outsourced to 3rd party vendors/CROs. Seek candidate accustomed to an outsourced model.-- This Director will be the company's Subject Matter Expert (SME) on Pharmacovigilance and Drug Safety and will represent the company to the FDA and other regulatory agencies. Seek superb communicator. Familiarity with EU regulations and practices would be valuable.-- This is an independent contributor Director-level role responsible for overseeing work done by internal and external partners. Seek natural leader who brings the operational and interpersonal savvy to get things done through the cooperation of others.-- This is both a strategic and tactical role. This Director will perform detailed reviews of Case Reporting, Signal Detection/Aggregate Analysis, etc. as well as provide thoughtful and strategic analyses of trends and signals. Seek candidate who will own the PV/Safety function - start to finish. Selected Duties:

  • Serve as the company expert and "go-to" person for post-marketing Pharmacovigilance.
  • Manage global Pharmacovigilance (PV) operations to ensure compliance with applicable regulatory PV requirements and guidances.
  • Manage external PV vendor(s) including quality oversight of case reporting, signal detection/aggregate analysis, safety data exchange agreements, and contract/budget management.
  • Ensure that the PV function (in house and outsourced), is operationalized according to the highest industry standards, as well as compliance with the company's policies and SOPs.
  • Drive Pharmacovigilance compliance and quality management function within PV to ensure compliance with local and international safety requirements and regulatory inspection readiness.
  • Oversee and contribute to the production of aggregate safety reports including PADERs, PBRERs. Provide relevant information and feedback to stakeholders for other aggregate reports (e.g., DSURs, IND annual reports, investigator brochures).
  • Manage vendor and partner audits, ensure inspection readiness and serve as lead contact for regulatory audits. Oversee and update SOPs. This position requires a person with a "can-do" attitude, who thinks strategically but is detail oriented, to achieve the precision, quality, and accuracy needed for Pharmacovigilance. Requirements include a related degree (strong preference for those with health science bkgd such as PharmD, Nursing, PA, etc.) as well as 5+ years in Pharmacovigilance in a pharma or CRO setting, including substantial experience with marketed drugs.Other priorities include:
    • Knowledge and track record in Pharmacovigilance operations including case management, individual and aggregate case reporting (US and EU).
    • Safety data review, signal detection (including individual and aggregate data analysis), risk management, labeling, and benefit-risk assessment in the context of aggregate reports (PBRER)
    • Documentation and communication of safety assessments; Knowledge of Safety Databases
    • Advanced knowledge of FDA, EU regulations and ICH guidelines relating to Pharmacovigilance
    • Experience interfacing with regulatory agencies and other inspectors
    • Keen attention to detail and compliance orientation
    • Superb project management and process management skills
    • Ability to lead and influence cross-functional teams to achieve shared goals
    • Track record of longevity, impact and achievement
      Finally, we seek a candidate who will thrive in an emerging business setting; someone who is excited to be part of a growing organization, will be flexible, adaptable and versatile and will bring the insights, ideas and initiative to help build a Best Practices team.
      This is an immediate need. Please forward Word resume for prompt consideration.



Keywords: Frankel Staffing Partners, Raleigh , Director, Pharmacovigilance/Drug Safety (Marketed Products) - NC Pharm, Executive , Raleigh, North Carolina

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