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: 

• 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.
  

Qualifications: 

• 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.
  

Behavioral skills: 

• 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.