Manager, Quality & Compliance Pharmacovigilance in Bernards, NJ at DSI

Date Posted: 11/15/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Bernards, NJ
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    11/15/2018
  • Job ID:
    9382BR

Job Description

About Daiichi Sankyo Cancer Enterprise

The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA.

Job Summary

This position supports the head of CSPV Quality and Compliance in the establishment, implementation and oversight of the CSPV Quality, Compliance and Training function. This position is responsible for managing activities related to quality and compliance including but not limited to monitoring and trending of key performance indicators (KPIs) and compliance reports. This position leads audit/inspection readiness activities and represents quality and compliance during audits and inspections. This position conducts periodic quality assessments to measure and ensure adherence of CSPV processes and procedures by internal personnel and external vendors. This position manages and maintains an effective corrective action and preventive actions (CAPA) process including but not limited to the tracking, trend analysis and implementation of quality improvement measures and effectiveness checks. This position collaborates with the Training Manager to ensure training compliance within CSPV department. This position coordinates with the Document Control Manager to ensure maintenance and accuracy of procedures.

Responsibilities

Quality and Compliance:
  • Manages activities related to quality and compliance including but not limited to monitoring and trending of key performance indicators (KPIs) and compliance metrics reports relative to the safety reporting and regulatory submission of individual case safety reports (ICSRs) and aggregate periodic safety reports.
  • Drives and manages an effective corrective action and preventive actions (CAPA) process including but not limited to the tracking, trend analysis, root cause analysis and implementation of process improvement measures and effectiveness checks.
  • Collaborates with the Training Manager to ensure compliance with training requirements of CSPV personnel including but not limited to periodic review of training records and training materials to ensure optimal training quality.
  • Collaborates with the Document Control Manager to ensure maintenance and accuracy of procedures including but not limited to providing procedural recommendations based on inspection readiness assessments and coordinating on procedural document requests for audits and inspections.
Inspection and Audit Readiness:
  • Leads audit/inspection readiness activities including but not limited to conducting routine/periodic quality assurance assessments to measure and ensure adherence of CSPV processes and procedures by internal personnel and external vendors.
  • Support conduct of inspections and audits and closely collaborate with Global GCP/PV QA audit department in preparation of internal audits and regulatory inspections including review and provision of preemptive relevant documents.
  • Analyze audit and inspection findings and suggest remediation as well as maintain overview of CAPA responses (pending and final) and resulting measures.

Qualifications

Education and Experience
  • Bachelor’s degree required preferably in healthcare or life sciences
  • Minimum of five (5) years of experience in Pharmacovigilance
  • MS, RN, or PharmD preferred, or 7 years total pharmaceutical industry experience in one or more of the following areas: Drug Safety/Pharmacovigilance, Epidemiology, and Clinical Development
  • 3-4 years of direct experience in Pharmacovigilance Compliance, global setting preferred
  • Possesses strong knowledge of FDA regulations, clinical and safety databases.

Competencies
  1. Consistently monitors and assesses individual, team and/or vendor/CRO work to provide high quality deliverables that meet/exceed expectations; provides guidance to others within the function.
  2. Suggests innovative solutions to improve efficiency/effectiveness at the functional level; solicits input and evaluates suggestions from others within the function.
  3. Investigates complex issues thoroughly and formulates multiple potential solutions.
  4. Possesses proficient knowledge such as pharmacology, clinical research, medical terminology, global Data Entry conventions, validated systems, and in Good Documentation Practices
  5. Communicates effectively within the team, cross-functionally, regionally and globally as applicable; demonstrates clear written communication skills with internal and external team/stakeholders.
  6. Effectively manages shifting priorities; collaborates and communicates across functions to achieve critical priorities.
  7. Possesses a comprehensive understanding of the functional roles within the clinical trial process.

Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.