Pharmacovigilance Compliance Team Lead

Pharmacovigilance Compliance Team Lead

Requirements

• Associates/bachelor’s degree in pharmacy, life sciences, or a related field; advanced degree preferred.
• 3-5 years of experience in drug safety, pharmacovigilance, quality assurance, or a related field.
• Experience in pharmacovigilance databases and adverse event reporting systems is a plus.
• Excellent communication, interpersonal, and negotiation skills.
• Proven ability to manage multiple projects and maintain effective working relationships with coworkers, managers, and clients.
• Detail-oriented with a commitment to maintaining high standards of quality.
• Ability to make informed decisions under pressure and in complex situations.
• Ability to initiate assigned tasks and work independently with minimal oversight.
• Proven leadership experience, including the ability to work collaboratively in a cross-functional environment.
• Analytical mindset with the ability to identify and solve complex problems.
• Knowledge of Microsoft Office applications; word, excel spreadsheets, PowerPoint Etc.

Responsibilities

• Serve as the key quality and compliance leader for their respective client(s) and develop a good understanding of Patient Support Services operational processes and business objectives.
• Provide drug safety and pharmacovigilance leadership to the quality and compliance team, fostering a culture of collaboration, excellence, and continuous learning.
• Oversee the daily collection, evaluation, and processing of safety data in accordance with regulatory and client requirements ensuring implementation and maintenance of quality control measures.
• Maintain working knowledge of industry standards and client regulatory requirements, including changes, and ensure IQVIA’s continued compliance with pharmacovigilance regulations and guidelines.
• Lead the proactive identification of potential safety signals and collaborate with cross-functional teams to develop risk minimization strategies.
• Responsible for the preparation of weekly, monthly, and quarterly reconciliation reports for all required programs per client contractual obligations as well comprehensive monthly and quarterly quality and compliance reports specific to client business requirements.
• Communicate upcoming training requirements to ensure all team members receive appropriate training in support of achieving client KPIs and compliance to contract and regulatory requirements.
• Serve as quality and compliance subject matter expert in support of client audits/inspections, ensuring the proper conduct of customer-initiated audits and providing invaluable support during regulatory inspections. Rigorously evaluate audit findings, collaborate closely with relevant stakeholders to provide insights into audit observations and assist in the formulation of corrective action plans. Ensure timely follow-up on major and critical audit findings, ensuring that necessary actions have been taken to effectively resolve identified issues.

Preferred Qualifications

• Experience in quality assurance, preferably in life sciences or pharmaceutical industry is a plus.