Calliditas is a commercial-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. We have our headquarters in Stockholm, Sweden and offices in the USA, Switzerland and France.
Calliditas’ lead product, Tarpeyo™, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there were no approved treatments.
As of December 2021, the FDA has approved the commercialization of Nefecon (TARPEYO™) in the United States thus making it the first and only FDA-approved treatment and in May 2022 Calliditas received a positive opinion for the drug from CHMP in the EU. Calliditas is listed on Nasdaq Stockholm (ticker: CALTX) and the Nasdaq Global Select Market (ticker: CALT). Visit www.calliditas.com for further information.
The Associate Director, Pharmacovigilance Compliance and Training (AD PV Compliance / Training), based in the United States and reporting to VP Head of Pharmacovigilance, provides strategic oversight of the PV quality system, inspection program and PV quality risk management, promotes operational and compliance excellence, and provides ongoing safety intelligence to PV colleagues and other stakeholders. The individual is responsible for implementing and maintaining effective monitoring and control systems that ensure the global quality systems supporting the PV system are robust and aligned with all applicable regulations. Additional responsibilities for this individual include development and trending of metrics associated with PV key performance indicators (KPIs), maintenance of the training programs for PV employees in collaboration with the Head of PV, Human Resources (HR) and Training personnel, monitoring PV training compliance metrics, and contribution to the strategy for PV operational activities.
The AD PV Compliance / Training partners with different functions across the globe that impact the PV system to identify quality and compliance risks, conducts robust investigations and develops adequate corrective and preventive actions (CAPAs), managing changes and facilitating continual improvement that is aligned to Calliditas’ values and strategic priorities.
The AD PV Compliance / Training frequently partners with the Quality Assurance (QA) Department to ensure that the PV activities, procedures, and inspection readiness measures are aligned with the Quality Management System for Calliditas Therapeutics. This individual will also partner with HR to ensure that training plans for PV staff and PV training materials for other employees, such as the AE Reporting Training, are aligned with HR procedures.
The individual will work from the New York, NY office. Flexibility for remote work is provided in accordance with the current hybrid work model.
Vaccination is a requirement, subject to any religious or medical accommodation.
Key tasks and responsibilities
- Leads the pharmacovigilance system inspection readiness program.
- Develops, implements and maintains a strategic plan for inspection readiness.
- Plans logistical details for inspections in the US such as the communication tree, introductory company slide deck, location of inspection room and war room.
- Lists, organizes and maintains access to materials required for an inspection such as training records, periodic reports, etc.
- Engages with relevant functions and stakeholders to ensure inspection readiness, driving accountability and transparency. In addition to PV, functions include, but are not limited to QA, Office Managers, Human Resources, Regulatory Affairs, Clinical Development, Medical Affairs and Legal.
- Identifies quality and compliance inspection risks, and proactively provides strategic and comprehensive mitigation.
- Hosts PV inspections or audits (including, but not limited to, QA audits and mock inspections) and provides strategic direction to relevant functions and Subject Matter Experts (SMEs). May also host and manage business partner PV audits in collaboration with QA.
- Ensures a robust communication plan is in place, that enables knowledge sharing of insights and risks in preparation and during an inspection.
- Leads and manages the inspection response activities, ensuring the appropriate persons participate in the inspection, that responses are adequate and timely, and that responses are reviewed and approved internally by the relevant stakeholders, at the right levels and at the appropriate time.
- Acts as SME of PV Compliance and Training activities and provides inspection or audit responses regarding the PV Quality System, including but not limited to CAPAs, deviation management, PV quality investigations, effectiveness checks, etc.
- Communicates the progress of inspections or audits at least daily, summarizing succinctly the inspection activities and potential observations and mitigation activities.
- Effectively and timely escalates to management.
- Ensures the impact of a finding is thoroughly assessed, the appropriate root cause is identified, and specific, measurable, achievable, relevant and timebound CAPAs are developed.
- Facilitates and documents an effective debriefing session for each inspection or audit that promotes lessons learned and knowledge management.
- Supports and provides relevant guidance to other non-PV-specific inspections and audits (e.g., GMP, GCP, etc.).
- Leads cross-functional continual improvements projects that enable compliant quality PV systems.
- Leads the strategy for development and maintenance of PV controlled procedures (SOPs and work instructions) based on relevant regulatory requirements, regulatory commitments and industry guidelines.
- Authors, reviews, and approves controlled procedures related to pharmacovigilance to ensure regulatory requirements, regulatory commitments and important industry guidelines are considered, e.g., the ICH guidelines and CIOMS working group recommendations.
- Coaches PV staff in safety intelligence to support capability building and talent development.
- Facilitates PV training meetings that provide ongoing safety intelligence to the PV employees and other employees, in coordination with QA and other functions.
- Escalates issues of potentially critical non-compliance to senior management. Analyzes results, quality issues and investigation to identify actionable trends and propose remediations that promote a state of compliance.
- Drives the development and monitoring of relevant metrics and key performance indicators (KPIs) for PV in collaboration with the PV team. Mitigates communicates and escalates any risks flagged by the metrics, ensuring actions are commensurate to the risk and timely.
- Maintains a schedule of key timelines, in compliance with applicable regulatory requirements, industry guidelines and Calliditas controlled procedures, for PV deliverables such as periodic reports and signal detection reports, and monitors updates to PV documents such as controlled procedures, Risk Management Plans (RMPs) and Development RMPs.
- Reviews compliance, KPI and training metrics with Head of PV on an ongoing basis.
- Maintains individual training plans for PV staff, contributes to PV Department training plans and monitors training compliance for PV staff in collaboration with the Head of PV.
- Partners within PV colleagues and with other functions to ensure alignment of PV activities with internal procedures and company business objectives.
Education and experience requirements
- Bachelors, postgraduate or professional degree in life science, health/epidemiology, or medical field.
- Minimum of 6 years of relevant experience in the global pharmaceutical industry in the PV field, with at least 5 years of experience in GVP Quality/Compliance.
- Advanced knowledge of pharmaceutical development and GCP/GVP regulations and guidelines, including but not limited to: FDA, EU, MHRA, PMDA, ICH guidelines and CIOMS working group reports.
- Experience in successful development and implementation of a pharmacovigilance audit program, leading regulatory inspections and remediation activities on a global level.
- Experience in managing complex organizational compliance issues and in identifying and implementing organization-wide compliance initiatives.
- Experience in writing controlled procedures (SOPs and Work Instructions), managing the strategy to develop new controlled procedures and to update existing procedures.
- Skilled in problem solving, organized and able to manage global, cross-functional projects.
- Excellent interpersonal, oral, and written communications skills with the ability to effectively interact with business stakeholders, associates and at all levels of management.
- Proficiency with Microsoft Office Suite applications and an electronic data management system.
- General knowledge of safety databases such as Aris Global or Argus, and individual case safety report formats such as MedWatch and CIOMS I forms.
- Able to work both collaboratively and independently. Self-starter. Takes initiative and works independently to successfully work in a fast-paced environment with multiple demands.
- Meets deadlines.
- Maintains high ethical standards.
Reasons to join the Calliditas Team
- Be a part of a global leader in IgA-Nephropathy and a rapidly growing commercial-stage pharmaceutical company within specialty products with strong growth ambitions and a strong pipeline
- Be a part of the commercialization of TARPEYO™ in the US and Nefecon via partners in other countries
- Fast paced small company environment
- A unique corporate culture
- Dedicated, experienced and highly skilled colleagues
- Participate on bonus and benefit programs
Welcome to join the Calliditas Team!