Vice President Drug Safety And Pharmacovigilance

Overview

The Vice President 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: 15+ 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.