Senior Manager - Compliance and Drug Safety and Pharmacovigilance Operations

Blueprint Medicines is a global, fully integrated biopharmaceutical company that invents life-changing medicines. We seek to alleviate human suffering by solving important medical problems in two core focus areas: allergy/inflammation and oncology/hematology. Our approach begins by targeting the root causes of disease, using deep scientific knowledge in our core focus areas and drug discovery expertise across multiple therapeutic modalities. We have a proven track record of success with two approved medicines, including bringing our medicine to patients with systemic mastocytosis (SM) in the U.S. and Europe. Leveraging our established research, development, and commercial capability and infrastructure, we now aim to significantly scale our impact by advancing a broad pipeline of programs ranging from early science to advanced clinical trials in mast cell diseases including SM and chronic urticaria, breast cancer and other solid tumors.

Job Title: Senior Manager - Compliance and Drug Safety and Pharmacovigilance Operations

Location: Cambridge - Remote. Attends On-Site Meetings.

Hours - 15 hours/week

• Reporting to the Senior Director of Drug Safety and Pharmacovigilance Operations, the Senior Manager, Contractor, of Compliance and DSPV Operations is responsible for supporting the operational delivery of the PV Quality system, inspection program, promotes operational and compliance excellence, and for ensuring PV activities follow regulatory requirements and corporate and departmental procedures. This position requires ability to influence and partner with internal and external colleagues and with senior management.
  
  

Responsibilities

• Complete and assist with the oversight of the monitoring and control systems for supporting the PV System and PV Quality System, including Manage Pharmacovigilance System Master File.
• Subject matter expertise on all aspects of safety operations and overall data quality during audits/inspections.
• Development, reporting, and trending of metrics associated with PV Key Performance Indicators (KPI) to DSPV Leadership of the PV Quality System.
• Partner with Quality and relevant stakeholders with the generation, review, and approval of governing documents, such as SOPs, Operating Guidelines and Safety Management Plans, as necessary, and ensure operational implementation, regulatory requirements and commitments, and important industry guidelines are considered (e.g. ICH guidelines and CIOMS working group).
• Maintenance of the training programs with Quality for DSPV Staff and vendors.
• Provide functional support & input to set up or manage vendor relationships (e.g., contract details, safety management plans).
• Liaisons with Quality and assists with managing the inspection readiness for DSPV including but not limited to organizing the DSPV function and engaging with relevant stakeholders and functions to ensure worldwide inspection readiness for clinical and post marketing inspections, responses are reviewed and approved internally by relevant stakeholders.
• Monitor compliance with Safety Data Exchange Agreement with partners, as required.
• Monitor timely submission of expedited safety reports and other external submissions through effective vendor management and performance metrics review.
• Partner with QA and maintain overall department oversight of DSPV’s internal and vendor investigations, deviations, CAPA management, and effectiveness checks.
• Assists with the Oversight of the management and archival of DSPV Records/documentation.
• Other responsibilities as required.
  
  

Qualifications

• Ability to work independently and productively and set priorities across multiple projects with little supervision.
• Ability to promote team collaboration, fosters open dialog, maintains an inclusive collaborative environment, keeps a team focused on a common goal and maintains positive momentum through difficulties.
• Prior PV Operations experience including case processing and reporting of clinical trial and post marketing reports
• Must work effectively/collaboratively in a fast-paced team environment and with individuals at all levels within an organization.
• Good 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
  
  

Experience

• Minimum 5 years in Drug Safety/Pharmacovigilance in pharmaceutical industry setting with prior experience in PV Compliance.
• Minimum 3-5 years’ experience working with CROs, vendors, and relationship management preferred.
• Experience in GCP/GVP regulation and guidelines, including but not limited to US FDA, EU, ICH Guidelines and CIOMS working group reports.
• Experience with regulatory inspections and company audits including USA/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.

• Minimum of bachelor’s level degree in nursing, pharmacy, or other health care related profession or life sciences or in science and engineering required.
• Master’s or Doctorate level degree in health care related profession preferred but not essential
  
  

Pay Transparency

The pay range that Magnit reasonably expects to pay for this position: $110.00 - $115.00 /hour.

Benefits: Medical, Dental, Vision, 401K (provided minimum eligibility hours are met).

Why Blueprint?

At Blueprint Medicines, we achieve impactful results because of our global crew of compassionate innovators – the Blue Crew. Through authentic relationships and our collective entrepreneurial spirit and action, we are each empowered to take ownership and execute with strategic prioritization. We put trust in our people to break through norms and conventions using their individual strengths and insights, which drives our success.

This is the place where the extraordinary becomes reality, and you could be part of it.

Patients are waiting. Are you ready to make the leap?

Equity, Diversity, Inclusion and Affirmative Action

At Blueprint Medicines, we foster a culture of equity, diversity, and inclusion. A proud Equal Employment Opportunity and Affirmative Action employer, we consider all qualified applicants without regard to race, color, sex, gender identity or expression, sexual orientation, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, or any other characteristic protected under applicable law. We are also an E-Verify Employer. We will make reasonable accommodations, absent undue hardship, for qualified individuals with known disabilities. If you are an individual with a disability in need of accommodation with the application or recruiting process, please reach out to TotalRewards@blueprintmedicines.com.

For more information, please see our EEO-AA Policy Statement, the EEO Know Your Rights Poster, as well as our Pay Transparency Statement.

Job Location: Cambridge, Massachusetts

Contract Duration: 12 months

• Work Authorization : Green Card, US Citizen
• Preferred years of experience : 5
• Travel Required : No travel required
• Shift timings: Not specified