Director, PV Scientist

Kardigan•Princeton, NJ

2d•Hybrid

About The Position

Kardigan is hiring a Director, PV Scientist for its Pharmacovigilance Department. The department monitors, identifies, and evaluates adverse drug reactions and medication-related risks, working with healthcare professionals and regulatory authorities to protect patients and support drug safety and regulatory compliance. It collaborates across Clinical Development, Regulatory Affairs, Medical Affairs, Quality, Clinical Operations, and Commercial functions to turn safety data into evidence-based benefit-risk judgments. The role serves as the safety lead for one or more cardiovascular assets, from first-in-human studies through commercialization. It leads or supports product safety, risk management, signal detection and management, safety analyses, aggregate reporting, safety documentation, and regulatory filings. The position also contributes to safety governance, inspections and audits, pharmacovigilance quality systems, vendor oversight, and technology-enabled improvements to safety surveillance and decision-making. Initially an individual-contributor role, it may develop to include direct reports and management of internal or external staff. The position is based in Princeton, New Jersey, with a hybrid schedule requiring on-site work four days per week, Monday through Thursday. Travel of up to 5% is required. The stated pay range is $204,000–$250,000 USD; exact compensation may vary based on skills, experience, and location.

Requirements

Bachelor’s degree in life sciences, pharmacy, nursing, or an equivalent health-related discipline.
At least 8 years of drug safety or pharmacovigilance experience in the pharmaceutical or biotechnology industry.
Experience performing signal detection and safety surveillance using clinical trial, post-marketing, and scientific literature data.
Scientific writing experience, 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 Good Pharmacovigilance Practice (GVP).

Nice To Haves

Advanced degree in a life sciences discipline (MS, PharmD, or 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 Risk Evaluation and Mitigation Strategy (REMS).
Experience supporting health authority inspections or pharmacovigilance audits.
Cardiovascular therapeutic area experience.
Excellent oral, written, and collaboration skills, including the ability to explain complex safety issues simply and influence cross-functional partners and governance committees who are not direct reports.
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 applicable to signal detection, aggregate reporting, safety surveillance, and benefit-risk assessment.
Hands-on experience with drug safety database systems, electronic data capture, document management systems, and quality control tools, including MedDRA.
Attention to detail and a strong analytical mindset, with the ability to translate strategy into action and communicate complex issues simply.
Ability to thrive in a fast-growing, evolving, innovative environment while remaining flexible, proactive, resourceful, and efficient.

Responsibilities

Serve as the safety lead for one or more cardiovascular assets from first-in-human studies through commercialization, supporting product safety, risk management, and benefit-risk assessment throughout the product lifecycle.
Support risk management strategy planning and execution; author the Company core risk management plan, EU Risk Management Plan (RMP), and Risk Evaluation and Mitigation Strategy (REMS), as required.
Support signal detection, validation, analysis, prioritization, assessment, and action recommendations using clinical trial, post-marketing, scientific literature, and real-world evidence data; prepare escalations to Company safety governance committees.
Author aggregate safety reports and support safety analyses and data visualizations for governance committees, regulators, and cross-functional partners.
Coordinate the creation and maintenance of safety and benefit-risk management strategy sections for clinical trial protocols, Investigator’s Brochures (including reference safety information), informed consent forms, safety management plans, clinical study reports, aggregate safety reports, risk management plans, Company Core Safety Information, and other labeling.
Coordinate individual case safety review of adverse event reports throughout the product lifecycle and review aggregate safety data and relevant scientific literature for assigned assets.
Serve on pharmacovigilance safety governance teams evaluating benefit-risk changes and their impact on Company safety strategy and risk management.
Translate safety risk management, risk communication, and signal management decisions into regulatory documents and filings, including New Drug Applications and responses to safety queries from regulatory agencies and business partners.
Represent pharmacovigilance during health authority inspections, third-party audits, and internal process audits within the role’s remit.
Draft, review, and maintain pharmacovigilance standard operating procedures, work instructions, training documentation, and related quality materials.
Oversee vendors supporting pharmacovigilance operations, including due diligence, pharmacovigilance agreements, ongoing monitoring, and issue escalation.
Serve as a subject matter expert for pharmacovigilance Quality Management System enhancements; select and implement safety surveillance and analytical tools, and partner on technology-enabled, data-driven process improvements.
Work with pharmacovigilance physicians and stakeholders across company functions to support compliance with pharmacovigilance risk management measures and an integrated pharmacovigilance system.
Potentially manage direct reports and internal or external staff supporting operational pharmacovigilance activities as the role develops.
Serve as an internal and external authority on development and post-marketing safety requirements, including ICH guidelines, US and international regulations, and Good Pharmacovigilance Practice; keep the company current on advances in signal detection and safety data analysis.
Represent pharmacovigilance on project teams, in departments, and on committees as needed.