Overview

The Senior Director of Pharmacovigilance is a key leadership role responsible for overseeing the safety monitoring of pharmaceutical products throughout their lifecycle. This position ensures compliance with global regulatory requirements, manages risk assessment activities, and leads a team dedicated to safeguarding patient safety. The Senior Director collaborates cross-functionally with clinical, regulatory, and commercial teams to support product development and post-marketing surveillance.  The Senior Director of Pharmacovigilance plays a pivotal role in ensuring the safety of patients and the success of pharmaceutical products. This position requires a blend of scientific expertise, regulatory knowledge, and strong leadership to navigate the evolving landscape of drug safety.

Key Responsibilities

• Strategic Leadership
  • Develop and implement the overall pharmacovigilance strategy for the organization.
  • Provide expert guidance on safety risk management and regulatory compliance.
  • Represent the pharmacovigilance function in executive meetings and cross-functional projects.
• Safety Surveillance & Risk Management
  • Oversee the collection, evaluation, and reporting of adverse events for all products.
  • Lead signal detection, risk assessment, and mitigation activities.
  • Ensure timely submission of safety reports to regulatory authorities.
• Regulatory Compliance
  • Maintain up-to-date knowledge of global pharmacovigilance regulations (e.g., FDA, EMA, ICH).
  • Ensure all pharmacovigilance activities meet international standards and company policies.
  • Prepare for and participate in regulatory inspections and audits.
• Team Leadership & Development
  • Manage, mentor, and develop a high-performing pharmacovigilance team.
  • Allocate resources effectively to meet project and compliance deadlines.
  • Foster a culture of continuous improvement and professional growth.
• Cross-Functional Collaboration
  • Work closely with clinical development, medical affairs, regulatory affairs, and commercial teams.
  • Provide safety input for clinical trial protocols, informed consent forms, and product labeling.
  • Support due diligence and integration activities for business development initiatives.

Qualifications

• Education: Advanced degree in pharmacy, medicine, life sciences, or a related field (e.g., PharmD, MD, PhD).
• Experience: 12+ years in pharmacovigilance, with at least 5 years in a leadership role.
• Expertise: In-depth knowledge of global pharmacovigilance regulations and best practices.
• Skills: Strong leadership, communication, and organizational skills; ability to manage complex projects and teams.
• Certifications: Certification in pharmacovigilance or drug safety (preferred).

Key Competencies

• Analytical Thinking: Ability to interpret complex safety data and make informed decisions.
• Attention to Detail: Ensures accuracy in safety reporting and documentation.
• Collaboration: Builds effective relationships across departments and with external partners.
• Adaptability: Responds effectively to changing regulatory landscapes and business needs.
• Ethical Judgment: Maintains the highest standards of integrity and patient safety.