Associate Director, Pharmacovigilance Scientist

Location: Remote within the United States; periodic travel to hirify.global offices is required, and the role must work Eastern Time Zone hours.

Salary: $181,000–$235,000 USD annually, plus potential discretionary annual bonus and long-term incentive award.

Company

hirify.global is a clinical-stage biotechnology company developing precision therapies for autoimmune and inflammatory diseases.

What you will do

• Provide scientific and medical oversight for pharmacovigilance activities across immunology and inflammation clinical programs.
• Lead signal detection through safety database data mining, disproportionality analyses, and systematic literature reviews.
• Conduct benefit-risk assessments and support regulatory responses, labeling updates, and risk management strategies.
• Author and oversee DSURs, PSURs/PBRERs, PADERs, line listings, and other aggregate safety reports.
• Review complex individual case safety reports and provide medical oversight of narratives, coding, and regulatory compliance.
• Collaborate with Clinical Development, Regulatory Affairs, Medical Affairs, and safety governance bodies on monitoring, submissions, labeling, and risk minimization.

Requirements

• Advanced degree required; PharmD or PhD in a biomedical or clinical discipline strongly preferred.
• At least 7 years of pharmacovigilance or drug safety experience in the pharmaceutical or biotechnology industry.
• Knowledge of FDA 21 CFR, EU GVP Modules, ICH E2A–E2F guidelines, and MedDRA coding conventions.
• Experience with signal detection programs, pharmacovigilance databases, EBGM/PRR analyses, safety literature reviews, and aggregate safety reports.
• Strong medical case review and scientific communication skills, including experience with complex and medically significant cases.
• Must be able to work Eastern Time Zone hours and travel domestically up to 10% or more as business needs require.

Nice to have

• Experience with DSMB materials, clinical protocols, Investigator Brochures, Clinical Study Reports, RMPs, and REMS development.
• Experience in immunology, inflammation, and biologics development.

Culture & Benefits

• Remote work with periodic in-person collaboration and business travel.
• Flexible work arrangements and a hybrid schedule.
• Health and wellness coverage tailored to the hiring country and region.
• Paid time off, public holidays, and additional leave in accordance with local requirements.