Director, Product Lead, Clinical Safety & Pharmacovigilance (CSPV)

Location: Princeton, New Jersey, United States

Salary: $209,599–$313,375 annually, plus incentive opportunity.

Company

hirify.global Pharmaceutical Companies develops and commercializes pharmaceutical products and healthcare solutions.

What you will do

• Oversee the safety profiles of assigned investigational and marketed drugs and devices across clinical development and post-market stages.
• Develop and maintain signal detection processes and plans, with emphasis on early-stage risk identification.
• Embed safety considerations into clinical trial protocols, dose-escalation strategies, first-in-human assessments, and early development portfolio reviews.
• Analyze adverse events and prepare or review safety summaries, periodic reports, risk management plans, individual case safety reports, and related product documentation.
• Author and review safety sections for global regulatory submissions, including INDs, NDAs, MAAs, and other filings.
• Represent Clinical Safety and Pharmacovigilance in governance meetings and interactions with regulatory agencies, licensing partners, CROs, investigators, and internal stakeholders; mentor safety staff.

Requirements

• MD degree with a US medical license required.
• At least 5–7 years of pharmaceutical-industry experience as a safety or pharmacovigilance professional.
• Strong medical background and knowledge of FDA and global pharmacovigilance regulations, clinical trials, GCP, and ICH guidelines.
• Expertise in early development safety strategy, including first-in-human risk assessment.
• Experience preparing and reviewing safety content for IND, NDA, MAA, and other global regulatory filings.
• Strong scientific analysis, communication, leadership, collaboration, and organizational skills.

Nice to have

• Experience with both clinical development and product launch or post-marketing products.
• Direct experience in early development safety monitoring and strategy.
• Experience interacting with global regulatory authorities.

Culture & Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage.
• Company-provided life, accidental death and dismemberment, and short- and long-term disability insurance.
• Tuition reimbursement and student loan assistance.
• 401(k) match, flexible time off, paid holidays, and paid leave programs.
• Fast-paced environment focused on accountability, strategic thinking, patient centricity, respectful collaboration, and professional development.