Medical Director of Drug Safety and Pharmacovigilance

Overview

• Lead strategic initiatives in drug safety and pharmacovigilance, ensuring patient safety and regulatory compliance throughout product lifecycles.
• Collaborate with cross-functional teams to enhance safety measures and implement innovative pharmacovigilance practices.
• Provide expert medical guidance in safety assessments for clinical trials and marketed products.
• Represent the organization in regulatory interactions, external collaborations, and industry forums.
• Develop and oversee training programs to enhance team expertise in drug safety and pharmacovigilance.
• Drive innovation in risk management strategies to ensure cutting-edge safety protocols.
• Contribute to the organization's mission of delivering safe and effective healthcare solutions globally.

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 for drug safety.
• Oversee adverse event data collection, analysis, and reporting processes to ensure accuracy and timeliness.
• Collaborate with Clinical Development, Regulatory Affairs, and Medical Affairs teams to align safety strategies.
• Lead safety signal detection, evaluation, and risk mitigation activities to safeguard patient health.
• Represent the organization in interactions with regulatory authorities and external stakeholders.
• Develop and deliver training programs to enhance pharmacovigilance expertise within the organization.

Job Requirements

• Doctor of Medicine (MD) degree is required for this role.
• Minimum of 12 years of experience in drug safety and pharmacovigilance.
• Proven leadership experience in pharmacovigilance operations and strategy development.
• 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.