Job Description
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 Drug Safety Specialist, Drug Safety & Pharmacovigilance Operations
Location: Cambridge, MA Job Summary: Reporting to the Senior Director of Drug Safety and Pharmacovigilance Operations, Senior Drug Safety Specialist, Contractor, of Drug Safety and Pharmacovigilance Operations (DSPV) will play a key role in drug safety Individual Case Safety Report processing across the clinical development and post marketing programs. The Senior Drug Safety Specialist, Contractor, DSPV Operations contributes to the day-to-day operational activities of the department and ensures that performed tasks comply with DSPV SOPs and policies, best industry standards and applicable regulations.
Responsibilities - Participate in assigned clinical study team meetings to provide pharmacovigilance support.
- Liaison with DSPV Operations and other Blueprint teams (i.e. study teams) on execution of study deliverables (i.e. study start up, safety management plans, SAE reconciliation, query management, TMF), aggregate reporting and post marketing activities, as required.
- Participated in sponsor oversight of Adverse Event/Serious adverse event processing and reconciliations by outsourced vendors, including the review of Individual Case Safety Report processing (case triage, data entry, coding review, sponsor approval and narrative writing), as well as monitoring of Individual Case Safety Report reporting within the Company Sponsored Safety Database.
- Supports monitoring of Quality of vendor of Individual Case Safety Report processing for clinical and post marketing cases
- Support the monitoring and performing of notification and/or submissions for Individual Case Safety Reporting for Clinical Trial submission cross functionally (e.g. CRO, Partner, Clinical, and/or Regulatory) with DSPV Systems Team
- Support DSPV Compliance with monitoring reports (i.e. KPI) and other oversight activities and ensure the implementation of effective corrective and preventative action plans.
- Supports 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.
- Supports the daily management and execution of Drug Safety and Pharmacovigilance operations cross functionally.
- Additional safety related duties assigned.
Qualifications - Minimum of 3 years of Drug Safety/Pharmacovigilance case process in a pharmaceutical industry setting.
- Prior experience working with CROs, vendors, and relationship management preferred.
- Global pharmacovigilance operations experience with products in development.
- Previous experience with ICSR workflow steps and Safety database (LSMV/ARISg preferred), MedDRA coding and data entry experience and data entry conventions.
- Knowledge of ICH Good Pharmacovigilance Practices and Good Clinical Practices.
- Anticipate and proactively resolve issues when and where possible.
- Knowledge of FDA and EU legislation and ICH Efficacy guidelines.
- Strong analytical, problem-solving skills with superb attention to detail, and able to organize workload to prioritize most urgent deliverable.
- Strong verbal, written technical communication and presentation skills.
- Must work effectively/collaboratively in a fast-paced team environment and with individuals at all levels within an organization.
- Proven ability to work within a cross-functional, matrixed team.
- Bachelor’s 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, but not essential
Pay Transparency The pay range that Magnit reasonably expects to pay for this position: $70.00 - 75.00 /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: 10 months
- Work Authorization : Green Card, US Citizen
- Preferred years of experience : 5+yrs
- Travel Required : No travel required
- Shift timings: Not specified
Job Tags
Contract work, For contractors, Immediate start, Gangs, Shift work,