Pharmacovigilance Compliance Team Lead

Job Overview:

This position holds a central role in our commitment to quality and compliance, and your dedication and expertise will be instrumental in ensuring our ongoing success. As a self-starter with a keen eye for detail and a commitment to excellence, you will thrive in this dynamic and critical role. Your ability to communicate and collaborate effectively, coupled with your strong analytical and problem-solving skills, will enable you to make a significant impact on our organization's quality and compliance efforts.

Role Purpose:

• We are seeking a highly motivated and experienced Quality and Compliance Team Lead to join our dynamic team. The successful candidate will be entrusted with a wide range of responsibilities to ensure that our organization adheres to the highest standards of quality and compliance. This role requires a strong leader with a deep understanding of commercial patient services, pharmacovigilance, quality assurance, and regulatory compliance.
• As a Quality and Compliance Team Lead, you will serve as a liaison to key clients, where your leadership and expertise will contribute to the continuous improvement of our drug safety processes, regulatory and contract compliance, and overall patient safety. This role will require reporting and client facing interaction.
• You must thrive in a team environment and possess the ability to coach and mentor individuals as needed.

Responsibilities:

Your duties will encompass the following key areas:

• The Quality and Compliance team lead will serve as the key quality and compliance leader for their respective client(s) and is expected to 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. Promptly address any discrepancies and respond to client inquiries.
• 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. Support training delivery as needed.
• 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.

Minimum Required Education & Experience:

• 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.

Required Knowledge, Skill and Abilities:

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

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IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe