Manager, Pharmacovigilance QA

KPS Life is seeking a PV specialist/manager level role with at least 2 years of experience in PV-Quality related roles. Ideally the individual would be in the Eastern Time Zone based remotely in the USA.

• Timeline: ASAP through end of Dec (possibly extended)
• Minimal travel, maybe 25% for onsite audits
• Veeva experience required
  
  

Reporting to the Sr. Manager Pharmacovigilance QA, the Manager of Pharmacovigilance QA serves as a strategic partner managing quality and regulatory compliance related to Good Pharmacovigilance Practices (GVP) and other related activities performed by Drug Safety & Pharmacovigilance and Medical/Clinical Departments. The incumbent will provide support and promote collaboration internally and externally to ensure all systems, processes and their outcomes comply with applicable international and national standards, regulations and guidelines in partnership with relevant functions (i.e., Drug Safety and Pharmacovigilance (DSPV) and Medical Information (MI))

Responsibilities (Essential Role Responsibilities)

• Conduct and/or assist with Pharmacovigilance external supplier audits (such as PV vendors and Specialty Pharmacies) including planning, execution, and reporting.
• Provide guidance to staff to ensure the proposed corrective actions received from the auditees are appropriate and that Quality Events/CAPAs are monitored to completion.
• Supports the evaluation and acceptability of Pharmacovigilance vendors for potential use.
• Review and approve PV related Deviations, Quality Events, CAPA, Effectiveness Checks and Root Cause Analysis Investigations (including but not limited to Specialty Pharmacies, Market Research Vendors, DSPV PV Vendor)
• Assist in the review and provide input into the quality sections of the Pharmacovigilance System Master File.
• Support the creation of systems and processes, Standard Operating Procedures (SOPs) / Work Instructions (WI), and other PV related documents.
• Support Regulatory Authority inspections including inspection preparation training and support; actively support during the inspection and provide input and review of responses to inspection observations and regulatory agency questions resulting from inspections.
  
  

Position Requirements (Required And/or Preferred Skills, Experience And Education)

• Minimum BS degree in Chemistry, Biology or related life sciences discipline required with minimum 3 years of experience, 2 years of which are in Pharmacovigilance.
• Advanced degree (MS, PhD, MBA) preferred. In lieu of advanced degree, additional years of equivalent experience will be considered.
• Certified auditing experience preferred.
• Requires experience with pharmacovigilance in Phases I-IV (particularly Phase III) and post-marketing.
• Basic knowledge and understanding of drug and device FDA, EU and ICH regulations, pharmacovigilance regulations/processes and HA inspection procedures is required.
• Experience developing SOPs, reviewing pharmacovigilance, clinical, regulatory and medical processes to ensure they are accurately represented in current SOPs is essential.
• Ability to conduct external audits on PV vendors, CROs, Specialty Pharmacies and monitoring organizations with responsibility for writing audit reports as well as reviewing and tracking CAPAs.