What are the responsibilities and job description for the Senior Director, Pharmacovigilance Scientist position at DBV Technologies?
Description
The Senior Director, Pharmacovigilance Scientist drives the development of safety surveillance strategies for assigned programs and indications across the product lifecycle, ensuring compliant, efficient, and high-quality safety surveillance activities in accordance with global regulatory requirements. The role partners closely with cross-functional stakeholders in a fast-paced, growing biotech environment. This position is based in our Warren, New Jersey office on a hybrid schedule (three days in-office per week).
Location: Warren, New Jersey - 3 days on site & 2 days remote
Salary Range: 200-250K
Key Responsibilities
We are on a mission to advance epicutaneous immunotherapy using our innovative technology platform, Viaskin™, to develop treatment options for immunologic diseases with significant unmet medical need.
This mission drives our commitment to the advancement of treatments for patients and their families. That is why we are investigating a potential new class of immunotherapy, epicutaneous immunotherapy (EPIT), that aims to re-educate the immune system of patients through the skin.
Today, we are focused on exploring the use of Viaskin to address food allergies, a devastating condition that afflicts millions of patients. As an important milestone in our journey, we hope to offer the first epicutaneous immunotherapy treatment for peanut allergy.
Tomorrow, as pioneers, we will continue to explore the broad applications of this potential new class of immunotherapy, including treatments for patients suffering from inflammatory and autoimmune diseases.
The Senior Director, Pharmacovigilance Scientist drives the development of safety surveillance strategies for assigned programs and indications across the product lifecycle, ensuring compliant, efficient, and high-quality safety surveillance activities in accordance with global regulatory requirements. The role partners closely with cross-functional stakeholders in a fast-paced, growing biotech environment. This position is based in our Warren, New Jersey office on a hybrid schedule (three days in-office per week).
Location: Warren, New Jersey - 3 days on site & 2 days remote
Salary Range: 200-250K
Key Responsibilities
- Represent the PV function in cross-functional projects and teams, partnering with Drug Safety Physicians to develop safety surveillance strategies and contribute to benefit-risk assessments for assigned products.
- Support the evaluation and management of safety signals from all data sources, including signal detection, benefit-risk profile assessment, and aggregate reporting activities.
- Oversee, prepare, and/or review safety documents including periodic safety reports (PSURs/PBRERs), DSURs, signal evaluation reports, risk management plans, and other safety-related documents.
- Formulate and contribute to responses to health authority inquiries related to product safety.
- Partner with the Clinical team to support safety management plans and medical monitoring strategies for clinical programs.
- Bachelor's degree in, Pharmacy, Medicine or related healthcare professional field required; advanced degree (MS, PharmD, PhD, MD) preferred.
- Minimum 12 years of experience in pharmacovigilance within the biopharmaceutical industry.
- At least 8 years of experience in signal detection and safety surveillance activities.
- Proficiency with safety surveillance tools and safety databases (e.g., Empirica Signal, LifeSphere Advanced Signals, AEMS, EVDAS, ).
- Experience building or scaling PV signal detection processes in a growing organization.
- Strong knowledge of global pharmacovigilance regulations and guidelines (FDA, Health Canada, EMA, ICH).
- Excellent communication, leadership, and cross-functional collaboration skills.
- Ability to operate independently and strategically in a small, evolving organization.
- Prior experience in immunology, pediatrics, or related therapeutic areas.
- Experience supporting clinical development safety programs in a biotech setting.
- Curiosity: Keep on exploring uncharted territories. Always ask “why?” and more importantly “why not?”,
- Courage: Take smart risks, mentor each other to always do better & be accountable for our choices, our opinions, and our actions,
- Collaboration: Teamwork and spirit. Support each other and be equally involved in the achievement of our common goals,
- Credibility: Be transparent, follow through and build trust. Educate ourselves about our unique technology.
We are on a mission to advance epicutaneous immunotherapy using our innovative technology platform, Viaskin™, to develop treatment options for immunologic diseases with significant unmet medical need.
This mission drives our commitment to the advancement of treatments for patients and their families. That is why we are investigating a potential new class of immunotherapy, epicutaneous immunotherapy (EPIT), that aims to re-educate the immune system of patients through the skin.
Today, we are focused on exploring the use of Viaskin to address food allergies, a devastating condition that afflicts millions of patients. As an important milestone in our journey, we hope to offer the first epicutaneous immunotherapy treatment for peanut allergy.
Tomorrow, as pioneers, we will continue to explore the broad applications of this potential new class of immunotherapy, including treatments for patients suffering from inflammatory and autoimmune diseases.