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Kardigan · 1 week ago

Director, Pharmacovigilance Scientist

Princeton, NJ

Full-time

Onsite

Director/Executive

$209K/yr - $272K/yr

8+ years exp

Kardigan is a heart health company focused on making cardiovascular disease preventable and curable. The Director, PV Scientist will be responsible for overseeing the patient safety benefit-risk program for company assets, managing risk management activities, and ensuring compliance with pharmacovigilance regulations.

Artificial Intelligence (AI)BiopharmaHealth CareMedical

H1B Sponsor Likely

Responsibilities

Risk Management and Minimization: For assigned asset(s), lead the development of risk management activities, including strategy planning, risk management plan execution. Writes the company core risk management plan and REMS, as required

Signal Detection/Management: Leads signal detection, validation, analysis and prioritization, assessment and recommendation of action activities for assigned asset(s) for the continuous benefit-risk evaluation throughout the product lifecycle. Contributes/leads preparation for escalation to company safety governance committees

Safety Analysis Reporting: Collaborates with/Leads the preparation of safety analysis reports and visualizations to communicate key insights

Safety Documentation Management: For one or more assets, coordinates with PV Physicians and other stakeholders the creation and management of relevant safety/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

ICSR Safety 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, performs aggregate data safety review and the review of relevant scientific literature articles for assigned asset(s)

Ongoing Safety Oversight: For assigned asset(s), serve as a member of the PV safety governance teams for the evaluating of benefit-risk changes and the impact to company safety strategy and risk management activities

Regulatory Documentation Support: Supports the implementation of safety risk management, risk communication and signal management decisions into key regulatory document sections regulatory filings, New Drug Applications (NDAs), and responses to safety queries from third-parties, such as regulatory agencies

Audit and Inspection Support: Function as the PV representative for Health Authority Inspections, third-party audits and Internal Process Audits within the remit of role and responsibility

SOP and Quality Documentation Management: Leads the drafting, reviewing and maintaining PV department SOPs, work instructions and related materials such as training documentation within the remit of role and responsibility

Third-party Oversight: Support the oversight of vendors supporting company PV operations throughout the engagement including contributing to due diligence, pharmacovigilance agreements, ongoing monitoring and issue escalation

Support PV and IT Process Improvements: Function as the SME for PV QMS enhancements. Additionally, serve as the PV SME to ensure supporting IT applications and analytical tools are configured and maintained to support the business needs and facilitates accurate reporting and analytics

Stakeholder support: Works closely with PV 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

You will champion excellence in drug safety and PV practices throughout the company. Responsible for staying up-to-date with the latest advancements in signal processing and data analysis techniques

Provides expert guidance and leadership both internally and externally based on in-depth knowledge of development and post-marketing safety requirements, per ICH; US and international regulations and guidelines; and Good Pharmacovigilance Practice (GVP)

Represents PV on project teams, other departments, and committees as needed

Qualification

Drug SafetyPharmacovigilanceSignal DetectionData AnalysisScientific WritingPharmacovigilance RegulationsStatistical ModelingMachine LearningAnalytical MindsetCommunication SkillsAttention to DetailLeadership SkillsInterpersonal Skills

Required

Bachelor's degree in life sciences, pharmacy, nursing or equivalent health experience

Minimum of 8-10 years of experience in Drug Safety / Pharmacovigilance role in pharmaceutical industry

Proven experience in signal detection and data analysis of data from various sources

Proficiency in data analysis tools

Experience in scientific writing

Thorough understanding of pharmacovigilance regulations

Excellent communication and collaboration skills

Attention to detail and a strong analytical mindset

Strong knowledge and experience with currently available drug safety database systems, document management systems and QC tools

Excellent oral and written communication skills

Strong interpersonal and leadership skills and demonstrated ability to manage, motivate and influence work behaviors of individuals who are not direct reports

Must thrive working in a fast growing/evolving, innovative environment while remaining flexible, proactive, resourceful and efficient

Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations

Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks

Preferred

Advanced Life Sciences Degree or MBA

Managerial role in drug safety

Experience in biopharmaceuticals

Strong knowledge of statistical modeling and machine learning algorithms

Operational expertise with Safety database

Company

Kardigan

Kardigan develops personalized medicines using AI and data to target and treat the root causes of cardiovascular diseases.

Founded in 2023

South San Francisco, California, USA

51-200 employees

https://www.kardigan.bio

H1B Sponsorship

Kardigan has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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2025 (1)