Associate Director/Director, Drug Safety & Pharmacovigilance (Quality & Compliance)

Responsibilities

• Provide strategic guidance and leadership to the pharmacovigilance quality assurance team.
• Develop and implement a comprehensive quality assurance strategy aligned with organizational goals.
• Develop/oversee execution of (end-to-end) PV QA processes and systems to ensure compliance/alignment with regulatory requirements and internal policies/procedures.
• Proactively provide Good Pharmacovigivalence Practice (GVP) support for clinical, post marketing and commercial activities including PV/safety systems to protect patient safety and well-being, maintain data integrity, and support implementation of Quality Systems.
• Monitor industry trends, regulatory changes, and best practices to ensure continuous improvement of quality assurance processes.
• Monitor vendor key performance indicator (KPI) metrics and implement measures to enhance the quality of CROs and vendors.
• Lead the development, review, and maintenance of Standard Operating Procedures (SOPs) for pharmacovigilance quality assurance activities.
• Ensure that SOPs are consistent with current regulations, guidelines, and industry standards.
• Manage a team of quality assurance professionals, including training, mentoring, and performance evaluations.
• Foster a collaborative and high-performance work environment to achieve departmental objectives.
• Conduct regular internal audits of pharmacovigilance processes, systems, and data to ensure compliance with regulatory requirements.
• Collaborate with internal audit teams and external partners during regulatory inspections and audits.
• Develop and implement key quality metrics to assess the effectiveness of pharmacovigilance processes.
• Prepare and present quality assurance reports to senior management, highlighting trends, issues, and opportunities for improvement.
• Collaborate with cross-functional teams to assess and manage risks related to pharmacovigilance activities. Identify areas of potential risk and implement strategies to mitigate them proactively.
• Drive continuous improvement initiatives to enhance the efficiency and effectiveness of pharmacovigilance quality assurance activities.
• Regularly assess quality and compliance initiatives for effectiveness, outcomes, and relevance, and adjust strategy as needed based on results, risks, and feedback.
• Engage with stakeholders to solicit feedback and implement process enhancements.
• Monitor regulatory intelligence and surveillance activities for emerging regulations in any geography that may impact PV system.
• Oversee corrective and preventative actions (CAPA) development, execution, closure and, as needed, escalation for CAPAs associated or impacting pharmacovigilance.
• Contribute to drug safety and pharmacovigilance issue management to support early issue detection, CAPA development and completion tracking, and effectiveness assessment for PV systems.

Requirements

• 8 years of experience in pharmacovigilance or drug safety, with 6 years in a quality assurance or compliance role.
• Bachelor's Degree in a related scientific field.
• Strong understanding of global pharmacovigilance regulations, guidelines, and industry best practices.
• Proven experience in leading and managing teams, including demonstrated leadership skills and the ability to mentor and develop staff.
• Excellent communication skills, both written and verbal, with the ability to interact effectively with cross-functional teams and external stakeholders.
• Detail-oriented with strong analytical and problem-solving capabilities.
• Experience in conducting internal audits and managing regulatory inspections is desirable.
• Proficiency in using pharmacovigilance databases and software.