Director, Pharmacovigilance Scientist

The role

The Director, PV Scientist will serve as the safety lead for cardiovascular assets from first-in-human studies through commercialization. This role involves managing risk management activities, signal detection, and authoring aggregate safety reports and regulatory documentation.

What you will do

• Serve as the safety lead for cardiovascular assets from first-in-human studies through commercialization.
• Support risk management activities including strategy planning and execution.
• Author the Company core risk management plan, EU RMP, and REMS.
• Support signal detection, validation, analysis, and prioritization.
• Prepare escalations to Company safety governance committees.
• Author aggregate safety reports and prepare safety analyses.
• Coordinate the creation and maintenance of safety and benefit-risk management strategy sections in clinical documents.
• Coordinate individual case safety review of Adverse Event reports.
• Serve as the pharmacovigilance representative for health authority inspections and audits.
• Oversee vendors supporting pharmacovigilance operations.

Required qualifications

• Bachelor's degree in life sciences, pharmacy, nursing, or an equivalent health-related discipline.
• Minimum of 8 years of drug safety or pharmacovigilance experience in the pharmaceutical or biotechnology industry.
• Experience performing signal detection and safety surveillance using data from clinical trial, post-marketing, and scientific literature sources.
• Experience scientific writing including authoring or leading aggregate safety reports, such as a DSUR, PBRER, or PADER.
• Working knowledge of global pharmacovigilance regulations and guidance, including FDA and EMA requirements, ICH guidelines, and GVP.

Nice to have

• Advanced degree in a life sciences discipline (MS, PharmD, PhD), or an MBA.
• Experience in biopharmaceuticals or a clinical-stage biotechnology environment.
• Managerial experience in drug safety, or experience overseeing outsourced pharmacovigilance resources and vendors.
• Experience authoring an EU Risk Management Plan (RMP) or a Risk Evaluation and Mitigation Strategy (REMS).
• Experience supporting health authority inspections or pharmacovigilance audits.
• Cardiovascular therapeutic area experience.
• Excellent oral and written communication and collaboration skills.
• Knowledge of statistical modeling and machine learning algorithms.
• Knowledge of advanced analytics, digital health technologies, artificial intelligence, machine learning, real world evidence analysis, or automation technologies.
• Hands-on experience using a drug safety database systems, electronic data capture, document management systems, and quality control tools, including MedDRA.

About the company

Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. It aims to develop multiple targeted treatments in parallel to bring people with cardiovascular diseases to the cures they deserve.