At Blueprint Medicines, as our name indicates, we are creating a blueprint for the future of healthcare. We are a leading company in the personalized medicine revolution by focusing on delivering new medicines that are targeted to the genetic driver of disease. We do this by leveraging our one-of-kind drug discovery platform to discover, develop and work to bring highly-selective kinase inhibitors to patients globally. This prolific scientific platform has enabled Blueprint Medicine to build a pipeline of novel therapies that span three distinct areas of medicine; genomically defined cancers, rare diseases and cancer immunotherapy.
Reporting to the Vice President of Drug Safety and Pharmacovigilance, the Head of Drug Safety and Pharmacovigilance Operations (Associate Director/Director) is responsible for the operational management and oversight of case processing activities performed internally and externally by vendors (CROs), expedited safety reporting and partner data exchange. The successful candidate will be responsible for ensuring all ICSR processing is in compliance with regulatory requirements and corporate and departmental procedures. This position requires ability to influence without directly managing and partnership with internal and external colleagues in matrix teams and with senior management. Supervision and management of internal safety operations personnel as the department expands.
- Subject matter expertise on safety operations and overall data quality during audits/inspections.
- Continuous improvement and maintenance of a robust oversight plan related to internal and external case processing (e.g., monitoring reports, quality evaluations).
- Functional support / input to set up vendor relationships (e.g., business requirements, vendor selection, contract details, vendor oversight / safety management plans).
- Partner with PV Quality, Compliance and Infrastructure in the generation, review and approval of governing documents, such as SOPs, Operating Guidelines and Safety Management Plans, as necessary, and ensure operational implementation.
- Partner with PV Quality, Compliance and Infrastructure in the review of PV vendor metrics reviews; develop and implement CRO case processing vendor improvement plans, as needed, evaluate outcomes of implemented improvement plans
- Exchange of safety data with partners, as required
- Ensure timely submission of expedited safety reports and other external submissions through effective vendor management and performance metrics review. Partner with PV Quality, Compliance & Infrastructure to identify CAPAs required to address late reporting. Partner with PV Quality, Compliance & Infrastructure to maintain current PV regulatory intelligence in the company safety database
- Provide PV operational support to clinical trial study teams; Partner with PV Quality, Compliance and Infrastructure for data generation required to support the study teams, to develop and monitor adverse event reporting site performance metrics
- Develop adverse event receipt and processing structure in preparation for product launch; partner with medical affairs to identify post-marketing vendors and reporting strategy
- Partner with PV Quality, Compliance and Infrastructure on activities required in preparation for product launch
- Supervision and management of internal safety operations personnel as the department expands.
- Other responsibilities as required
- Ability to work independently and productively and set priorities across multiple projects with little supervision.
- Exhibits leadership skills that promotes team collaboration, fosters open dialog, maintains an inclusive collaborative environment, keeps a team focused on a common goal and maintains positive momentum through difficulties.
- Must work effectively/collaboratively in a fast-paced team environment and with individuals at all levels within an organization.
- Proven ability to lead a cross-functional, matrixed team.
- Expert knowledge of FDA and EU legislation and ICH PV guidelines.
- Prior NDA / MAA experience preferred.
- Strong analytical and problem solving skills with superb attention to detail.
- Strong verbal, written technical communication and presentation skills
- Minimum of Bachelor’s level degree in nursing, pharmacy, or other health care related profession or life sciences
- Master’s or Doctorate level degree in health care related profession preferred.
- Minimum 3 years in Drug safety/Pharmacovigilance in pharmaceutical industry setting or the equivalent.
- Minimum 2 years’ experience working with CROs, vendors, and relationship management preferred.
- Successful leadership / senior level experience in global pharmacovigilance operations with pre-approved products.
- Experience with selection and working with contract service providers for case processing, aggregate reporting and quality management activities.
- Extensive experience in performance management of PV systems.
- Experience with regulatory inspections and company audits including MHRA/EMA PV inspections.
All applicants will receive consideration for employment without regard to race, color, age, religion, sex, national origin, disability or protected veteran status.
WHO WE ARE:
Blueprint Medicines’ mission is to dramatically improve the lives of patients with genomically defined diseases. Our singular focus is to use our deep understanding of the genetic blueprint of cancer and other diseases driven by the abnormal activation of kinases to craft highly selective medicines aimed at eradicating these diseases.
We don’t think in small steps. We think in giant leaps.
We are driven by the pursuit of new ideas, new innovations, and new ways of thinking.
We know that what each and every one of us does matters and that our success depends on our ability to work together. We believe we are at our best as a company when our employees are thriving and foster a culture that provides opportunities to grow and develop professionally, while also having fun.