Director, Pharmacovigilance Scientist

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).

• 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.