Director, Safety Physician

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.

Who we are looking for:

The Safety Physician, Global Pharmacovigilance, should be a physician with training and experience in Pharmacovigilance and Risk Management in the pharmaceutical/biotech industry to contribute to the overall medical oversight and safety evaluation within Pharmacovigilance and Risk Management. This position is responsible for the proactive and timely risk-benefit assessments of safety data to characterize the emerging and known safety profiles of development and marketed company products. The Safety Physician assists in the successful development, execution and maintenance of safety-related strategies, processes and systems that conform to the company’s business strategy, industry standards and compliance with global regulations. This individual will provide guidance to third party vendors and to internal/external staff in the collection, evaluation and processing of adverse events from clinical trials and post marketing surveillance. This role provides an excellent opportunity to collaborate closely with colleagues from other functions such as Clinical Development, Clinical Operations, Regulatory Affairs and Medical Affairs.

Primary Responsibilities:

• Conduct medical review of individual case safety reports (ICSRs) including identification of appropriate follow-up requests of important medical information for the proper medical assessment and evaluation of cases.
• Responsible for the review and communication of safety data trending, signaling and other safety related issues originating from any source for the purpose of detecting and reviewing safety signals in a timely manner via the Safety Governance process.
• Responsible for the development of review/response documents for safety issues arising from internal review or regulator feedback.
• Chair the multidisciplinary Safety Management Team whose responsibilities include safety surveillance (signal detection and evaluation), risk management planning, and making recommendations related to safety issues
• Participate in the preparation and maintenance of Reference Safety Information (RSI) and product labeling (e.g. Company Core Safety Information (CCSI), Investigator Brochure (1B), national labels), Risk Management Plans (RMP).
• Collaborate with key stakeholders including business partners in appropriate safety analyses and risk assessment and management strategies.
• Author medical-safety sections of aggregate safety reports (DSUR, PBRER)
• Participate in development of safety-related responses to queries from Regulatory Authorities
• Maintain knowledge of disease and therapeutic areas for marketed products and products in development
• Demonstrate knowledge and ensure compliance with applicable global PV regulations and guidelines (e.g. CIOMS, FDA, EMA, ICH, etc.).

Requirements:

• D./D.O Degree
• Experience in Pharmacovigilance, particularly with individual case review and evaluation.
• Autoimmune experience preferred.
• Experience with concepts of signal detection and review of aggregate data to identify potential emerging safety issues, benefit risk assessment, and risk management strategies.
• Knowledge of clinical development process
• Experience in the preparation and contribution to authoring of aggregate safety reports for regulator submission.
• Demonstrated ability to prioritize multiple tasks and deliver to deadline with high standard of quality.
• Experience with commercially available safety databases.
• At least three years of practical clinical experience post licensure
• At least three years of pharmacovigilance experience
• Knowledge of drug approval process in major countries.

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 https://www.vorbio.com/ for more information.