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Pharmacovigilance Systems Senior Manager
2 months ago
Pharmacovigilance Systems Senior Manager
Cambridge, MA
Requisition Number: 24-606
How will your role help us transform hope into reality?
Job Duties: Manage the day-to-day operational activities of the PV Systems and ensure that performed tasks comply with Drug Safety and Pharmacovigilance SOPs and policies, best industry standards, and applicable regulations.
What will you do?
Duties include:
Manage configuration of Blueprint Medicines’ Safety database, administering all the configuration requests related to Product Library, Study/Protocols, Automated distribution contacts (Reporting rules) and standard validations.
Develop and design custom and ad-hoc safety reports using SQL from the Safety database;
Create and automate all the validated listings and reports to the business stakeholders and partners.
Enhance the existing Safety database and reporting functionality to improve the efficiency in the process.
Identify and define database requirements and solutions for Blueprint’s Drug Safety PV (DSPV) database users;
Work closely with the PV Operations team and the CRO partners to effectively address any case processing related issues and recommend solutions wherever applicable.
Create processes in the safety database to manage the compliance and KPIs effectively.
Manage day-to-day troubleshooting issues and address inquiries related to the Safety database;
Collaborate with Safety database vendor for change controls, issue resolutions, and on-going database management projects;
Work closely with the Safety database vendor (ArisGlobal) to resolve any issues related to Safety database, raising any change controls in Veeva for upgrades and enhancements, reviewing the change logs and product upgrades.
Work with the Quality Assurance team (CSV) and Information Technology (IT) team to document the CAPAs and other quality items to ensure compliance with company and regulatory standards;
Create and maintain proper documentation for any changes on the Validated systems as part of the Change management process, working closely with QA (CSV) and IT to ensure any CAPAs and Quality Items are promptly opened and tracked to resolution.
Serve as project manager for the DSPV systems, managing all the key deliverables for all the various projects/initiatives within DSPV, ensuring that all the projects’ artifacts/documents are correctly captured in line with the GxP standards.
Support the safety database inspection and audits and provide responses to audit findings that concern the DSPV department;
Ensure that the Safety database is in inspection ready state at all times and provide required assistance during the inspection and audits.
Participate in the quality management system in Drug Safety including ensuring department standards are met, including training requirements, monitoring performance, implementing continuous improvement actions and good documentation practices.
What minimum qualifications do we require?
Position Requirements: Bachelor’s degree in Computer Science, Electrical Engineering or a closely related field (or foreign equivalent degree), plus 5 years of experience in Drug Safety systems and/or database management.
Experience, which may be gained concurrently, must include:
5 years of experience in SQL Programming and Reporting tools/frameworks.
3 years of experience in Drug Safety/PV in the pharmaceutical industry setting.
3 years of experience in supporting Drug Safety Databases (ARISg or ARGUS).
3 years of experience in Regulatory and compliance reporting.
3 years of experience in GxP processes and regulations related to Pharmacovigilance, including change control management.
5 years of experience in SDLC processes.
3 years of experience in Computer Systems Validation processes.
5 years of experience in Project management.
What additional qualifications will make you a stronger candidate?
Commitment to our Core Values: Patients First, Thoughtfulness, Urgency, Trust, Optimism
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 an 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.
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.
* This position is part of Blueprint Medicines’ employee referral program and is eligible for an employee referral incentive bonus.
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