Director Pharmacovigilance Scientist

About the Job

Job Title: Director, PV Scientist

Department: Pharmacovigilance

Reports to: VP, Head of Pharmacovigilance

Location: Princeton, NJ

Classification: Hybrid – On-site 4 days per week (Mon to Thurs)

Travel: Up to 5% travel required

About the Team

The Kardigan Pharmacovigilance Department is dedicated to ensuring the safe and effective use of the Company’s products by systematically monitoring, identifying, and evaluating adverse drug reactions and other medication-related risks. Through rigorous data collection, analysis, and collaboration with healthcare professionals and regulatory authorities, the department plays a vital role in safeguarding patient health and supporting the Company's commitment to the highest standards of drug safety and regulatory compliance. Working closely with colleagues across Clinical Development, Regulatory Affairs, Medical Affairs, Quality, Clinical Operations and Commercial functions, the team turns safety data into clear, evidence-based judgments about benefit and risk that shape how our programs are designed, communicated, and approved.

We are building a team where scientific rigor, sound judgment, and a practical, solutions-oriented mindset matter more than hierarchy. Team members have the opportunity to build the standards, systems, and technology-enabled ways of working that will support Kardigan's portfolio as it grows, and to see that work reflected directly in how patients living with cardiovascular disease are protected. 

Main Responsibilities

• Product Safety Leadership: Serve as the safety lead for one or more of Kardigan's cardiovascular assets, from first-in-human studies through commercialization, supporting product safety, risk management, and benefit-risk assessment across the product lifecycle.

• Risk Management and Minimization: For assigned assets, supports risk management activities, including strategy planning and risk management plan execution. Author the Company core risk management plan, the EU Risk Management Plan (RMP), and the Risk Evaluation and Mitigation Strategy (REMS), as required.

• Signal Detection and Management: Support signal detection, validation, analysis, prioritization, assessment, and recommendation of actions for assigned assets, using data from clinical trials, post-marketing experience, scientific literature, and real-world evidence to support continuous benefit-risk evaluation throughout the product lifecycle. Prepare escalations to Company safety governance committees.

• Safety Analysis and Reporting: Author aggregate safety reports and support the preparation of safety analyses and data visualizations that make complex findings clear to safety governance committees, regulators, and cross-functional partners.

• Safety Documentation Management: For one or more assets, coordinate with pharmacovigilance physicians and other stakeholders to create and maintain the safety and benefit-risk management strategy sections of clinical trial protocols, Investigator's Brochure (IB) (including the reference safety information section), informed consent form (ICF), safety management plan (SMP), clinical study reports (CSR), Aggregate Safety Reports, risk management plan (RMP), Company Core Safety Information, and other labelling, as necessary.

• Individual Case Safety Report (ICSR) Review: Coordinate the individual case safety review of Adverse Event reports for Kardigan products either within or external to the safety database throughout the lifecycle of the product for impact to the benefit-risk profile.  Additionally, perform aggregate data safety review and review relevant scientific literature for assigned assets.

• Ongoing Safety Oversight:  For assigned asset(s), serve on the pharmacovigilance safety governance teams that evaluate changes in benefit-risk and their impact on Company safety strategy and risk management activities. 

• Regulatory Documentation Support: Translate safety risk management, risk communication, and signal management decisions into key regulatory documents and filings, including New Drug Applications (NDAs) and responses to safety queries from third parties such as regulatory agencies and business partners. 

• Audit and Inspection Support:  Serve as the pharmacovigilance representative for health authority inspections, third-party audits, and internal process audits within the remit of role and responsibility.

• SOP and Quality Documentation Management: Draft, review, and maintain pharmacovigilance department standard operating procedures (SOPs), work instructions, and related materials such as training documentation within the remit of role and responsibility.

• Third-party Oversight: Oversee vendors supporting company pharmacovigilance operations throughout the engagement, including due diligence, pharmacovigilance agreements, ongoing monitoring and issue escalation. 

• Support PV and IT Process Improvements:  Function as the subject matter expert for pharmacovigilance Quality Management System (QMS) enhancements.  Additionally, select and implement the safety surveillance and analytical tools the team relies on, and partner within and across organizations to evaluate and implement technology-enabled, data-driven improvements to support signal detection, benefit-risk evaluation, and safety decision making.

• Stakeholder Support: Work closely with pharmacovigilance physicians to develop and maintain relationships across the company particularly in functions such as clinical development/operations, clinical data management, clinical supply, manufacturing, commercial, regulatory affairs, quality, vendor/external contracts/finance, medical affairs, and other functions as appropriate to ensure compliance with PV risk management measures and ensure an integrated PV system.

• Staff/Team Management: Initially functioning as an individual contributor, role may develop into managing of direct reports.  May be responsible for managing internal and external staff allocated to operational PV activities, creating a highly efficient team across insourced and outsourced resources.

• Subject Matter Expertise: Serve as an internal and external authority on development and post-marketing safety requirements, including International Council for Harmonisation (ICH) guidelines, US and international regulations, and Good Pharmacovigilance Practice (GVP), and keep Kardigan current on advances in signal detection and safety data analysis.

• Cross-Functional Representation: Represent pharmacovigilance on project teams, in other departments, and on committees as needed.

About You

Basic 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 Development Safety Update Report (DSUR), Periodic Benefit-Risk Evaluation Report (PBRER), or Periodic Adverse Drug Experience Report (PADER).

• Working knowledge of global pharmacovigilance regulations and guidance, including FDA and EMA requirements, International Council for Harmonisation (ICH) guidelines, and Good Pharmacovigilance Practice (GVP).

Preferred Qualifications:

• 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 with demonstrated ability to communicate complex safety issues simply and to 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 technologies applicable to signal detection, aggregate reporting, safety surveillance, and benefit-risk assessment.

• Hands-on experience using a drug safety database systems, electronic data capture, document management systems, and quality control tools, including the Medical Dictionary for Regulatory Activities (MedDRA).

• Attention to detail and a strong analytical mindset, with demonstrated ability to translate strategy into action and to communicate complex issues in a simple way.

• Ability to thrive in a fast-growing, evolving, innovative environment while remaining flexible, proactive, resourceful, and efficient.

Pay range 204000 - 250000 USD