Director, Drug Safety & Pharmacovigilance Scientist

Location: Onsite in Waltham, Massachusetts, United States

Base pay: $220,000–$240,000 per year

Company

hirify.global is a clinical-stage biotechnology company developing oligonucleotide therapeutics for genetically driven neuromuscular diseases, including Duchenne muscular dystrophy and myotonic dystrophy type 1.

What you will do

• Lead safety surveillance, signal detection, signal evaluation, risk classification, benefit-risk assessment, and risk management across clinical development programs.
• Review and interpret safety information from clinical studies, individual case safety reports, nonclinical studies, scientific literature, and aggregate datasets.
• Author and contribute to DSURs, PSURs/PBRERs, signal assessment reports, regulatory safety responses, and safety sections of clinical and regulatory documents.
• Present safety analyses, recommendations, and risk management strategies to cross-functional teams and governance committees.
• Partner with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Biostatistics, Data Management, Quality, and external vendors.
• Maintain pharmacovigilance procedures, provide training, oversee vendors, and implement improvements aligned with evolving regulations and industry standards.

Requirements

• Advanced degree in life sciences, health sciences, pharmacy, medicine, nursing, or a related discipline; 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, safety databases, MedDRA coding, ICSR workflows, and pharmacovigilance vendor oversight.
• Strong scientific judgment, analytical skills, technical writing, presentation, project management, collaboration, and stakeholder-influence skills.

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 clinical-stage biotechnology environment focused on patient safety and life-transforming therapeutics.
• Collaborate across a matrixed organization with internal functions and external vendors.
• Support a culture of scientific excellence, accountability, continuous improvement, and cross-functional collaboration.
• Employee position with a stated base-pay range of $220,000–$240,000 annually.