Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. We are committed to developing multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve. The Director, PV Scientist will be part of the Kardigan PV department, responsible for the development, management, execution, and oversight of all aspects of the patient safety benefit-risk program for one or more company asset(s) throughout the product(s') life cycle from development through marketing.
Requirements
- Risk Management and Minimization: For assigned asset(s), lead the development of risk management activities, including strategy planning, risk management plan execution.
- 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.
- 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.
- 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.
Benefits
- Paid Time Off
- 401k Matching
- Retirement Plan
- Visa Sponsorship
- Four Day Work Week
- Generous Parental Leave
- Tuition Reimbursement
- Relocation Assistance
