Clinical Quality Assurance

Duties:
Pharmacovigilance Quality Assurance - Sr. Associate
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
o Conduct and/or assist with the completion and evaluation of supplier pre-qualification surveys
o 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

Skills:
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.
Excellent communication skills, interpersonal skills and ability to work with individuals in all levels of the organization and externally
Proven skills in taking initiative and working independently
Attention to detail and accuracy
Broad knowledge of risk-based quality systems approaches consistent with post-marketing GVP
Computer proficiency with comprehensive working knowledge of MS Office products
Must exhibit the companies five (5) core values of: Passion, Respect, Integrity, Accountability and Collaboration.

Education:
Minimum BS degree in Chemistry, Biology or related life sciences discipline required with minimum 4-5 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

Pay Range: $40-48.46/hr