Vice President, Pharmacovigilance

Department: Clinical

Employment Type: Full Time

Location: Research Triangle Park, NC

Description

Role Overview

• Design and execute pharmacovigilance and safety strategies across asset portfolio, ensuring alignment with corporate objectives and regulatory requirements. Lead presentations of sophisticated safety topics both internally and externally.  
• Establish and oversee processes for clinical evaluations of adverse event (AE) reports, including causality assessment and severity of the AE.  Ensure the integrity and maintenance of the PV database.
• Ensure quality and compliance of safety narratives, case reports, and aggregate reports.  Develop, recommend, and oversee implementation of risk management and mitigation plans for pharmaceutical product.  
• Lead interactions with regulatory authorities on safety-related matters.  Oversee preparation and submission of periodic safety update reports (PSURs) and other regulatory documents, ensuring compliance with FDA, EMA, ICH, and other applicable regulations.
• Monitor safety profiles of products through post-marketing surveillance and clinical trials.
• Monitor external data (eg from regulators, from marketed products and from therapeutics in pre-clinical and clinical development) to inform decisions for Kriya programs.
•  Partner with cross-functional teams, including clinical, regulatory, CMC and quality assurance to integrate safety considerations into program strategy and ensure completion of corrective and preventative actions.
• Contribute to the development of risk management strategies as needed for Kriya programs at all stages of development and commercialization.

Experience & Skills and Work Environment

• MD, PhD in a relevant discipline or an equivalent degree.
• Minimum 15+ years of experience in pharmacovigilance or a related field.
• Gene therapy experience in a biotech/pharmaceutical company preferred.
• In-depth knowledge of pharmacovigilance 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. 
• Ability to critically evaluate clinical data.
•  Strong understanding of drug development and lifecycle management.
• Detail-oriented with strong organizational skills.
• Ability to work independently and as part of a team.
•  Proficiency in medical writing and documentation.
• Strong ethical standards and commitment to patient safety. 

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

Life at Kriya

• Time Off & Work-Life Balance: Flexible Time Off ∙ Paid Parental & Medical Leave ∙ Paid Company Holidays
• Health & Wellness:  Fertility & Family Building Benefits ∙ Medical, Dental, and Vision Insurance ∙ Employee Assistance Program (EAP) ∙ Life Insurance ∙ Short- and Long-Term Disability Coverage
• Financial Security: Equity ∙ 401(k) with Company Match ∙ Identity Theft Protection
• And More!