Director, Pharmacovigilance / Product Safety

TL;DR

Director, Pharmacovigilance / Product Safety (Drug Safety & Pharmacovigilance): Lead safety surveillance, risk management, and risk communication for assigned development and marketed products with an accent on safety signal detection, benefit-risk documentation, and compliant risk management systems. Focus on managing safety review teams, medical assessment of adverse event reports, and ensuring US/EU/International (ICH, EU GVP) compliance across critical safety documents.

Location: Fully remote (occasional US/domestic travel up to 20%)

Salary: $247,000.00–$337,000.00 Annual

Company

hirify.global is a global biopharmaceutical company focused on transforming the lives of patients with serious and rare diseases.

What you will do

• Review safety data across pre-clinical, clinical, post-marketing, and literature sources throughout development and after launch.
• Conduct safety signal detection activities, including monitoring, evaluation, interpretation, and appropriate management and communication of safety information.
• Lead Safety Review Team(s) for assigned products and compounds, managing cross-functional benefit-risk assessments and maintaining benefit-risk documents (e.g., Safety Signal Assessment Reports).
• Develop and manage a comprehensive risk management system for risk detection, assessment, and risk minimization.
• Provide medical expert safety input into critical clinical development documents (e.g., protocols/amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs).
• Ensure compliance of the Risk Management System, RMPs, and RMMs with US, EU, and International regulations and standards (including ICH and EU GVP), and support periodic safety reporting.

Requirements

• MD or DO plus 2 years of Clinical Patient Care experience.
• 5 years of experience in the pharmaceutical industry in Drug Safety/Pharmacovigilance with both investigational and marketed products.
• 3 years of experience with medical case reviews, aggregate reporting, safety surveillance, signal management and/or risk management.
• Ability to review and/or prepare scientific and regulatory documents from large volumes of information.
• Knowledge of national and international PV and regulatory guidelines.
• Ability to present drug safety topics to regulatory authorities at meetings/conventions (product defense is a plus).

Culture & Benefits

• Fully remote work with occasional travel for team meetings or events.
• Comprehensive medical, dental, and vision coverage plus mental health support and access to an Employee Assistance Program (EAP).
• Generous paid time off, flexible work schedules, and fertility/family-forming and caregiver support.
• 401(k) with company match, annual equity awards, and participation in an Employee Stock Purchase Plan (ESPP).
• Company-paid life and disability insurance and access to learning and leadership programs (LinkedIn Learning, workshops, mentorship).