KPS Life is hiring for a remote based PV Compliance Specialist to be fully dedicated to our sponsor client. If you have experience in the pharmaceutical industry with contract management and risk assessment of PV vendors and PV related vendors( Market research, Patient Support Program, Market access etc,) please reach out to us today to learn more about this long term assignment!
Position Summary:
Reporting to the Sr. Manager Pharmacovigilance QA, the Specialist 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:
- Support the evaluation and acceptability of vendors, partners and other external organizations related to PV activities such as Patient Support Programs, Specialty Pharmacies, and Market Research, for qualification
- Conduct and/or assist with the completion and evaluation of supplier pre-qualification surveys
- Creation and maintenance of vendor organization records related to PV activities in the QMS system
- Conduct risk assessments of vendors, partners, and other external organizations related to PV activities. Provide input for controls and monitoring of the vendors
- Provide input into the annual audit schedule of vendors, partners and other external organizations related to PV activities based on the output of the risk assessments
- 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
- Review and approve internal and external Deviations, Quality Events, CAPA, Effectiveness Checks and Root Cause Analysis Investigations
- 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:
- Minimum BS degree in Chemistry, Biology or related life sciences discipline required with minimum 3-4 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
- Requires experience with pharmacovigilance in Phases I-IV (particularly Phase III) and post-marketing
- Basic knowledge of Adverse Event (AE) reporting requirements and pharmacovigilance principles
- Basic knowledge of vendor management and contract management related to PV activities with business partners and external vendors such as Specialty Pharmacies, Patient Support Programs, Named Patient Programs, Market Research, and Market Access is required
- Basic knowledge of adverse event reporting requirement clauses within contractual agreements such as Safety Data Exchange Agreement (SDEA) with business partners, and Master Service Agreements/Statement of Works with vendors/third parties (i.e. Patient Support Programs, Specialty Pharmacies) is required.
- Basic knowledge and understanding of global pharmacovigilance regulations and guidelines, including, FDA, EMA and ICH regulations is required.
- Experience developing SOPs, reviewing pharmacovigilance, clinical, regulatory and medical processes to ensure they are accurately represented in current SOPs is preferred.
- 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 is preferred.