Global Pharmacovigilance (PV) Scientist, Manager (Oncology)

Location: United States - Remote

Salary: $116,167.80–$157,168.20 per year

Company

hirify.global is a biotechnology company developing medicines for serious illnesses across oncology, inflammation, general medicine, rare disease, and obesity-related conditions.

What you will do

• Lead signal detection, validation, evaluation, prioritization, and management using clinical, post-marketing, literature, epidemiological, and external data sources.
• Prepare and review aggregate safety reports, including PBRERs, PSURs, DSURs, Safety Assessment Reports, and regulatory safety responses.
• Provide safety input into clinical protocols, analysis plans, investigator brochures, clinical study reports, and safety data presentations.
• Support benefit-risk assessments, global risk management strategies, risk minimization activities, regulatory submissions, and health authority responses.
• Present safety analyses and recommendations to governance committees and collaborate with Clinical Development, Regulatory Affairs, Biostatistics, Medical Affairs, Epidemiology, and other stakeholders.
• Improve pharmacovigilance processes and methodologies while mentoring junior scientists and project team members.

Requirements

• Doctorate degree, or a master’s degree with 2 years, bachelor’s degree with 4 years, associate’s degree with 8 years, or high school diploma/GED with 10 years of industry pharmacovigilance experience.
• 5+ years of pharmacovigilance or drug safety experience in biotechnology, pharmaceutical, or CRO environments preferred.
• Experience with signal detection and management, aggregate safety reports, benefit-risk assessments, and risk management plans.
• Knowledge of FDA, EMA, ICH, and global pharmacovigilance regulations and guidance.
• Experience with Argus Safety or other global safety databases, regulatory submissions, inspections, audits, and health authority responses.
• Strong scientific judgment, communication, presentation, stakeholder management, and cross-functional leadership skills.

Nice to have

• PharmD, PhD, RN, NP, PA, MD, or another advanced scientific or healthcare degree.
• Experience in oncology, immunology, inflammation, rare disease, biologics, or related therapeutic areas.
• Experience supporting products in both development and post-marketing settings.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, vision, life, disability, and flexible spending benefits for eligible employees and dependents.
• Retirement and savings plan with company contributions.
• Annual bonus program, stock-based long-term incentives, and award-winning time-off plans.
• Flexible work models where applicable.

Hiring process

• Applications are accepted until a sufficient number of candidates are received or a candidate is selected.
• Sponsorship for this role is not guaranteed.