Vice President, Pharmacovigilance

Vice President, Pharmacovigilance

Department: Clinical Employment Type: Full Time Location: Research Triangle Park, NC

Description Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world. We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology.

We are proud to have been named Triangle Business Journals "Life Sciences 2024 Best Private Company to Work For," recognized by Forbes as one of Americas Best Startup Employers of 2024, and honored as one of BioSpaces 2025 Best Places to Work.

Role Overview The Vice President, Pharmacovigilance serves as a critical medical and data analytical role for Kriyas investigational and/or marketed products. They are responsible for designing and developing product safety surveillance programs. This role involves clinical evaluation of adverse event reports, risk assessment, and collaboration with various stakeholders to ensure regulatory compliance and patient safety.

Key Responsibilities

• Design and execute pharmacovigilance and safety strategies across the 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 products.
• 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 (e.g., from regulators) for 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

• 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.

Work Environment

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

Life at KriyaDiscover True Collaborative Teamwork We have an ambitious set of goals, but our confidence - and our inspiration - stems from our people. From California to North Carolina, our teammates bring a spirit of Collaboration, Leadership, and Innovation to their work every day. We are always looking for teammates with the drive and energy to help us grow. If you want to be a part of a company with an entrepreneurial culture, a bold vision, and a meaningful purpose, join us.

Rewards & Benefits

• 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, 401k with Company Match, Identity Theft Protection.
• And More.