Associate Director Pharmacovigilance Clinical Quality Audits & Compliance

Associate Director Pharmacovigilance Clinical Quality Audits & Compliance

Requirements

• Bachelor’s degree in a scientific field or related field.
• Minimum of 10 years as lead auditor in Pharmacovigilance and Clinical trials.
• Five (5) years of projects and audit management responsibilities in the biopharmaceutical industry.
• Must have strong background and experience in GVP/GCP compliance applicable to Global GVP and GCP regulatory requirements.
• An equivalent combination of relevant education and experience may be considered.

Responsibilities

• Conducts Pharmacovigilance and Clinical audits for studies and postmarketed products per EMA, FDA and MHRA regulations and guidelines.
• Plan, execute and complete Pharmacovigilance audit program based on risk assessment for all marketed products, clinical trials, vendors, and critical computerized systems and internal processes for ensuring adequate sponsor oversight in compliance EMA, FDA and MHRA regulation and guidelines.
• Audit activities include all aspects of planning, conducting, reporting, observations follow up and procedural documentation associated with internal and external audits and resource planning necessary to complete all audits. Ensure compliance to GVP, and GCP Quality Systems involving training, document management (SOPs and other controlled documents), change control, process improvement, and quality Quality systems activities will be coordinated with the Quality Systems group.
• Support regulatory inspections including, but not limited to, FDA, EMA, and other regulatory bodies as Provides management with updates and status responses to regulatory inspections.
• May act as Quality Assurance representative to assigned clinical studies and other development teams to ensure compliance with applicable regulations and industry guidance.
• Manage audit and quality systems for GVP/GCP functions including resource planning, budgeting and forecast support.
• Other duties as assigned.

Preferred Qualifications

• Exposure and collaboration with Drug Safety and Pharmacovigilance, Clinical Development and Operations as well as Medical Affairs and commercial stakeholders for marketed products such as Patient Access Program, and Specialty Pharmacies.
• Acumen and ability in GVP/GCP auditing, FDA and EMA regulations inclusive of direct experience with Pharmacovigilance, clinical trials and System Development Life Cycle activities.
• Excellent communication skills, both verbal and written with the ability to work independently as well as in a cross-functional, multi-cultural team with limited direction.
• String knowledge of applicable GVP and GCP domestic and international regulations and guidelines for clinical trials.
• Knowledge of GVP and GCP applicable domestic and international compliance audit concepts.
• Ability to interpret and apply practical knowledge of regulations and guidelines for the immediate resolution of compliance.
• Ability to assess regulatory/compliance risk, identify areas of improvement and propose practical solutions. Ability to interact successfully with internal and external stakeholders including Clinical Development, Regulatory Affairs, Drug Safety and Pharmacovigilance, Legal, Commercial, Sales and Marketing, etc.
• Skilled at negotiating with business partners or management and influencing leaders regarding matters of significance to the organization.
• Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals.