Senior Director Drug Safety and Pharmacovigilance

2 weeks ago


Boston, Massachusetts, United States Vor Bio Full time

Join Us in Tackling Autoimmune Disease at Its Root
At Vor, we believe science can do more than manage symptoms. It can change the course of disease. By advancing telitacicept, a first- and potentially best-in-class dual BAFF/APRIL inhibitor, we are silencing upstream survival signals and stopping downstream autoimmune cascades. Together, we are addressing disease at its root cause and rewriting what is possible for patients worldwide.

When you join Vor, you're not just working on a medicine. You're part of a mission to redefine the future of autoimmune care.

Why Work at Vor?
Impact: Contribute directly to a medicine with best-in-disease Phase 3 results in myasthenia gravis and expansion into multiple autoimmune diseases.

Growth: Be part of a rapidly scaling company with opportunities to grow your career in science, clinical development, commercial strategy, and beyond.

Innovation: Work on a platform with potential beyond one indication — a therapy that has already shown consistent results across lupus, IgA nephropathy, and Sjögren's syndrome.

Belonging: Join a culture where every voice is heard, and where our shared mission unites us across functions and geographies.

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.

At Vor, we support our team with robust benefits, including comprehensive health coverage, flexible paid time off, generous parental leave, and a competitive 401(k). From education assistance to wellness resources and financial security, we invest in your well-being so you can thrive at work and beyond.

As an equal opportunity employer, we at Vor Bio know that diversity inspires innovation, inclusiveness, and creativity. We invite you to come as you are. All applicants will be considered for employment agnostic to race, age, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Please visit our website at for more information.



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