Senior Director, Pharmacovigilance

Key Responsibilities

• Design and execute pharmacovigilance and safety strategies across Kriya's asset portfolio, ensuring alignment with regulatory requirements and corporate objectives.
• Establish and oversee processes for clinical evaluation of adverse event (AE) reports, including causality assessment, severity classification, and maintenance of the PV database.
• Ensure quality and compliance of safety narratives, case reports, and aggregate reports; develop and oversee implementation of risk management and mitigation plans.
• Lead interactions with regulatory authorities on safety-related matters; oversee preparation and submission of periodic safety update reports (PSURs) and other required regulatory documents in compliance with FDA, EMA, ICH, and other applicable regulations.
• Monitor safety profiles of products through post-marketing surveillance and clinical trials; track external safety data from regulators and comparable programs to inform Kriya’s decisions.
• Collaborate with cross-functional teams, including clinical, regulatory, CMC and quality assurance to integrate safety into program strategy and ensure completion of corrective and preventative actions (CAPAs).
• Contribute to risk management strategies at all stages of development and commercialization.

Experience & Skills

• MD or PhD in a relevant discipline; or an equivalent combination of education & experience.
• 12+ years of experience in pharmacovigilance or a related field.
• Gene therapy experience in a biotech/pharmaceutical company preferred.
• In-depth knowledge of pharmacovigivalence regulations and guidelines.
• Foster a culture of accountability, scientific rigor, and continuous improvement.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Proficiency in pharmacovigilance databases and software.
• Able to critically evaluate clinical data.
• Strong understanding of drug development and lifecycle management.
• Detail-oriented with strong organizational skills.
• Able to work independently and as part of a team.
• Proficiency in medical writing and documentation.
• Strong ethical standards and commitment to patient safety.

Work Environment

• Primarily desk-based, generally in an office or home office setting.
• Involves extended periods of sitting and computer use.