Medical Director of Drug Safety and Pharmacovigilance

Overview

• Lead strategic initiatives in drug safety and pharmacovigilance to ensure product safety throughout lifecycle stages.
• Collaborate with multidisciplinary teams to enhance safety measures and regulatory compliance.
• Provide medical expertise in safety assessments for clinical trials and marketed products.
• Drive innovation in pharmacovigilance practices and risk management strategies.
• Represent the organization in regulatory interactions and external collaborations.
• Develop and oversee training programs on drug safety and pharmacovigilance.
• Stay updated with industry advancements to maintain cutting-edge safety protocols.
• Contribute to the organization's mission of delivering safe and effective healthcare solutions.

Key Responsibilities & Duties

• Lead the Drug Safety and Pharmacovigilance team, providing strategic direction and operational oversight.
• Develop and implement comprehensive pharmacovigilance strategies and risk management plans.
• Ensure compliance with global regulatory requirements and industry standards.
• Oversee adverse event data collection, analysis, and reporting processes.
• Collaborate with Clinical Development, Regulatory Affairs, and Medical Affairs teams.
• Lead safety signal detection, evaluation, and risk mitigation activities.
• Represent the organization in regulatory authority interactions and external stakeholder engagements.
• Develop and deliver training programs to enhance pharmacovigilance expertise within the team.

Job Requirements

• Doctor of Medicine (MD) degree is required.
• Minimum of 12 years of experience in drug safety and pharmacovigilance.
• Proven leadership experience in pharmacovigilance operations and strategy.
• In-depth knowledge of global pharmacovigilance regulations and guidelines.
• Strong analytical and problem-solving skills to address safety concerns effectively.
• Excellent communication and interpersonal skills for cross-functional collaboration.
• Ability to thrive in a fast-paced, dynamic environment while maintaining high standards.
• Commitment to advancing safety measures and patient care in the healthcare industry.