Senior Director, Pharmacovigilance Scientist
DBV Technologies
8 hours ago
Remote friendly (Warren, NJ)
United States
Medical Affairs
Key Responsibilities
- Represent the PV function in cross-functional projects; partner with Drug Safety Physicians to develop safety surveillance strategies and support benefit-risk assessments.
- Evaluate and manage safety signals from all data sources (signal detection, benefit-risk profile assessment, aggregate reporting).
- Oversee, prepare, and/or review safety documents: PSURs/PBRERs, DSURs, signal evaluation reports, risk management plans, and other safety-related documents.
- Formulate and contribute to responses to health authority inquiries regarding product safety.
- Partner with Clinical to support safety management plans and medical monitoring strategies.
Qualifications
- Bachelor’s degree in Pharmacy, Medicine, or related healthcare field required; MS/PharmD/PhD/MD preferred.
- Minimum 12 years of pharmacovigilance experience in biopharmaceuticals.
- At least 8 years of experience in signal detection and safety surveillance.
- Proficiency with safety surveillance tools/databases (e.g., Empirica Signal, LifeSphere Advanced Signals, AEMS, EVDAS).
- Experience building/scaling PV signal detection processes.
- Strong knowledge of global pharmacovigilance regulations/guidelines (FDA, Health Canada, EMA, ICH).
- Strong communication, leadership, and cross-functional collaboration; ability to operate independently in a small evolving organization.
- Prior experience in immunology and/or pediatrics and experience supporting clinical development safety programs.
Salary Range: 200–250K.
- Represent the PV function in cross-functional projects; partner with Drug Safety Physicians to develop safety surveillance strategies and support benefit-risk assessments.
- Evaluate and manage safety signals from all data sources (signal detection, benefit-risk profile assessment, aggregate reporting).
- Oversee, prepare, and/or review safety documents: PSURs/PBRERs, DSURs, signal evaluation reports, risk management plans, and other safety-related documents.
- Formulate and contribute to responses to health authority inquiries regarding product safety.
- Partner with Clinical to support safety management plans and medical monitoring strategies.
Qualifications
- Bachelor’s degree in Pharmacy, Medicine, or related healthcare field required; MS/PharmD/PhD/MD preferred.
- Minimum 12 years of pharmacovigilance experience in biopharmaceuticals.
- At least 8 years of experience in signal detection and safety surveillance.
- Proficiency with safety surveillance tools/databases (e.g., Empirica Signal, LifeSphere Advanced Signals, AEMS, EVDAS).
- Experience building/scaling PV signal detection processes.
- Strong knowledge of global pharmacovigilance regulations/guidelines (FDA, Health Canada, EMA, ICH).
- Strong communication, leadership, and cross-functional collaboration; ability to operate independently in a small evolving organization.
- Prior experience in immunology and/or pediatrics and experience supporting clinical development safety programs.
Salary Range: 200–250K.