Director, Drug Safety & Pharmacovigilance Scientist

Location: Waltham, Massachusetts, United States; onsite

Salary: $220,000–$240,000 USD base pay annually

Company

hirify.global develops therapeutics targeting muscle and the central nervous system for genetically driven neuromuscular diseases, including Duchenne muscular dystrophy and myotonic dystrophy type 1.

What you will do

• Lead safety surveillance, aggregate safety review, signal detection, signal evaluation, and risk classification across clinical development programs.
• Review and interpret safety information from clinical studies, individual case safety reports, nonclinical studies, scientific literature, and other sources.
• Develop benefit-risk assessments, safety monitoring strategies, and risk mitigation plans throughout the product lifecycle.
• Author and contribute to DSURs, PSURs/PBRERs, safety signal assessments, regulatory responses, and safety sections of clinical and regulatory documents.
• Present safety analyses and recommendations to cross-functional teams, governance committees, and program teams.
• Enhance pharmacovigilance procedures, provide training, oversee vendors, and maintain inspection-ready documentation.

Requirements

• Advanced degree in life sciences, health sciences, pharmacy, medicine, nursing, or a related discipline required; MD, PharmD, PhD, or equivalent preferred.
• 10+ years of relevant pharmacovigilance, drug safety, clinical development, biotechnology, or pharmaceutical industry experience.
• Expertise in safety surveillance, signal detection and evaluation, aggregate safety review, benefit-risk assessment, and risk management for clinical-stage programs.
• Experience with DSURs, PSURs/PBRERs, safety signal assessments, regulatory safety responses, and clinical or regulatory documents.
• Knowledge of FDA, EMA, ICH, GVP, GCP, and applicable global safety reporting requirements, as well as safety databases, MedDRA coding, ICSR workflows, and vendor oversight.
• Strong scientific judgment, analytical and communication skills, technical writing ability, attention to detail, and experience influencing stakeholders in matrixed organizations.

Nice to have

• Experience in rare disease, neuromuscular disease, or clinical-stage biotechnology.
• MD, PharmD, PhD, or equivalent advanced degree.

Culture & Benefits

• Work in a patient-safety-focused biotechnology environment.
• Collaborate with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Biostatistics, Data Management, Quality, and external partners.
• Contribute to scientific excellence, operational rigor, accountability, and continuous improvement.
• Onsite position in Waltham, Massachusetts.