Vice President, Pharmacovigilance

Kriya Therapeutics•Morrisville, NC

2d•Hybrid

About The Position

The Vice President, Pharmacovigilance serves as a critical medical and data analytical role for Kriya’s 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.

Requirements

MD, PhD in a relevant discipline or an equivalent degree.
Minimum 15+ years of experience in pharmacovigilance or a related field.
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.

Nice To Haves

Gene therapy experience in a biotech/pharmaceutical company preferred.

Responsibilities

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.