Manager, PV Compliance
Middlesex County, MA
Manager, PV Compliance
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 medicines and multiple first-in-class investigational therapies in clinical and/or preclinical development.
Our Medical Safety and Risk Management (MSRM) team is seeking a self-starter with excellent knowledge in Pharmacovigilance (PV) and PV quality practices to be part of an innovative and fast-paced team supporting the companys product development activities.
Our Manager, PV Compliance will lead MSRM regulatory compliance oversight, nonconformance investigations, and Corrective and Preventative Action (CAPA) records in collaboration with other MSRM functions, Quality and other cross-functional stakeholders.
The Manager, PV Compliance will provide quality expertise to the MSRM team while overseeing and facilitating the PV Quality Management System, Veeva.
In addition, the Manager, PV Compliance will support MSRM quality and compliance activities including, but not limited to: audits and inspection readiness, training material development, revision and maintenance of departmental and cross-functional Procedures, documentation management, Pharmacovigilance System Master File (PSMF) maintenance.
Duties and Responsibilities:
- Manage MSRM regulatory non-conformances through investigations and the CAPA process records in collaboration with other MSRM functions and Quality.
- Manage ongoing CAPAs and ensure timely closing of records and effectiveness checks.
- Compile monthly and quarterly compliance metrics for MSRM.
- Lead MSRM internal compliance meetings.
- Support Agios PSMF maintenance as needed.
- Support internal audits, mock inspections and regulatory GVP, GCP and GMP inspections for PV-relevant topics.
- Support the development, update and management of SOPs and work instructions.
- Support the development of MSRM SharePoint pages and dashboards.
- Develop and perform PV quality related trainings for internal Agios staff and external suppliers.
- Develop, maintain and support others in the creation of departmental or sub-function training; support maintenance of MSRM training matrix/plan.
- Bachelors degree in a Life Sciences discipline, Nursing or Pharmacy.
- 4+ years of experience working within the Drug Safety/Pharmacovigilance domain
- PV quality or compliance experience
- Extensive experience with electronic Quality Management systems (e.g., Veeva, Trackwise) and other document management systems.
- Strong Attention to detail, results-oriented and persistent with excellent organizational and project management skills.
- Self-motivated with the ability to work independently in a fast-paced environment, prioritize multiple tasks and ability to recognize time sensitivity.
- Credible knowledge of global regulations governing Pharmacovigilance for products in clinical development and post-marketing.
- Strong interpersonal skills and the ability to effectively work individually and within a cross-functional team utilizing a customer service approach that is solution oriented.
- Strong oral and written communication skills
- Proficient MS Office and SharePoint skills.
- Ability to travel occasionally (up to 10%) for conferences, inspections, meetings and professional development activities.