Associate Director, Pharmacovigilance Quality (GVP)
Agios (agios.com) is a biopharmaceutical company committed to applying our scientific leadership in cellular metabolism to transform the lives of patients with cancer and rare genetic diseases. We are growing rapidly with an active research and discovery pipeline across both therapeutic areas. Agios has two approved oncology precision medicine and multiple first-in-class investigational therapies in clinical and/or preclinical development.
Agios is seeking a highly motivated Associate Director, Pharmacovigilance Quality to support all PV activities. The candidate should be able to develop the PV audit strategy and lead audits, provide expert Quality consultation to safety and clinical teams, lead inspection readiness activities and Health Authority audits, and provide direction to Agios stakeholders regarding GVP related activities/issues. The candidate should have the ability to identify and drive CAPAs and continuous process improvement initiatives through collaboration with their counterparts.
Oversight of pharmacovigilance (PV) quality and compliance system including establishing standards, department training requirements, monitoring department performance, implementing continuous improvement actions and good documentation practices.
Serve as the GVP Quality representative for clinical study teams (CTWGs).
Support the growth of the PV QMS, including continuous improvement of systems, processes and procedures.
Lead or participate in PV Health Authority inspections at Agios and support vendor inspections. Ensure robust CAPAs are developed and implemented in accordance with timelines.
Responsible for PV inspection readiness and tracking of documentation.
Ensure inspection readiness of vendors conducting PV activities through metrics review, vendor audit findings, CAPA generation and review, and training.
Conduct or participate in PV audits of vendors, processes and systems. Author audit reports and ensure completion of corrective and preventative actions (CAPA). Maintain and file related documentation as required.
Ensure that audit results are formally and consistently tracked, recorded, reported, trended. Ensure that corrective/preventive actions have been identified, documented and are effective.
Provide Drug Safety/PV Vendor oversight, including key performance indicator (KPI) metrics generation and review, contract compliance, quality and timeliness of deliverables and continuous improvement.
Support Quality management initiatives and Quality improvement plans for QA and defined business.
Provide oversight of QA consultants performing audits.
Develop and conduct PV training internally and to external partners and the call center, by partnering with Medical Safety and Risk Management.
Ensure PV and Call Center activities are conducted in compliance with applicable regulations/legislation, by-laws, regional and local guidelines and standards including EU, EU-GVP, ICH, FDA standards.
Maintain high level of knowledge of current global pharmacovigilance regulations, updates to regulations and good pharmacovigilance practices.
Bachelor's Degree in a scientific discipline
5+ years of experience in the pharmaceutical industry, including 3+ years in GVP Quality
Expert knowledge of FDA and EU legislation and ICH PV guidelines
Exhibits leadership skills that promotes team collaboration, fosters open dialog, maintains an inclusive collaborative environment
Must work effectively/collaboratively in a fast-paced team environment and with individuals at all levels within an organization
Strong verbal and written communication
Ability to travel up to 20%