Medical Director, Drug Safety & Pharmacovigilance 

Location: Cambridge, MA 

Requisition Number: 488

How will your role help us transform hope into reality?

Reporting to the Senior Medical Director or VP, Drug Safety and Pharmacovigilance, you will be responsible for the medical assessment of Individual Case Safety Reports (ICSRs) and drug safety information. You will actively assess and interpret safety data from multiple sources, including clinical trials, spontaneous and solicited reports, aggregate, and literature reports. Providing interpretation and summaries of drug safety information and input in the generation of safety reports (e.g., DSURs, PSUR and clinical safety assessments). You will serve as an integral part of a group of safety professionals, working in partnership with safety teams in Contract Research Organizations (CROs) and partners. You are a lifelong learner who will maintain medical knowledge as required by the role. Strong and current knowledge of drug safety, pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk-management practices will be applied to transform hope into reality for patients globally.

What will you do?

• Provide medical expertise in the assessment of ICSRs and aggregate safety data.
• Lead the creation of aggregate safety reports including development safety update reports, periodic benefit risk evaluation reports, and provide medical input in review of new or existing safety documents to ensure compliance with relevant regulatory requirements, such as protocols, safety summaries and regulatory reports.
• Provide support to internal PV Operations.
•  Effectively lead ongoing safety surveillance & detection activities, including the identification of new safety signals/emergent safety concerns to ensure timely assessment and communications.
• Serve as a medical resource for the generation and review of clinical trial protocols, informed consent forms (ICFs), investigator brochures (IBs) and other clinical documents as required.
• Contribute to the creation and/or updates to Risk Management Plans (RMPs) and the maintenance of the document. 
• Develop and craft Standard Operating Procedures, Working Instructions, and other documentation. 
• Build and deliver drug safety and Pharmacovigilance training programs.
• Collaborate with Global Regulatory Science and other relevant functions to ensure appropriate reporting of safety information to regulatory agencies and HCPs. 
• Work in a cross-functional setting with Medical Directors and Clinical Research Scientists, and vendor clinical staff who provide medical monitoring support for ongoing clinical trials.
• Provide subject matter expertise to external vendors and partners.

What minimum qualifications do we require? 

• 3- 5 years’ experience in Drug Safety/Pharmacovigilance in a pharmaceutical or biotech company, CRO or regulatory agency
• Medical Degree (MD) from recognized medical school with medical practice experience.

What additional qualifications will make you a stronger candidate? 

• Strong understanding of US and EU drug safety regulations, CIOMS and ICH guidelines.
• Proven experience with medical safety assessments and monitoring activities.
• Proficiency with medical review of ICSRs, including expectedness assessments, causality assessments, narrative review and generation of Analysis of Similar Event and company comment statements, including benefit-risk assessment.
• Experience with safety data collection and interpretation originating from clinical trials and other sources (such as the literature, solicited and post-marketing environment)
• Preparation of aggregate reports (DSUR, PSUR/PBRER, PADER).
• Established proficiency preparing responses to Regulatory Authorities.
• Expertise with IND/NDA submissions including negotiations with Regulatory Authorities as part of marketing approval.
• Experience with developing and updating Reference Safety Information, including IB, Company Core Data Sheet (CCDS) and local labels.
• Ability to build positive relationships, collaborate, and influence across teams within Blueprint Medicines and outside partners.
• Excellent verbal, written and presentation skills.
• 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?

COVID-19 Vaccination Requirement

As a biotechnology organization, it is our responsibility to do everything we can to safeguard the health and safety of our workforce, our communities, and the patients we serve. That is why, prior to their start date, new hires must provide confirmation that they are fully vaccinated against COVID-19, or be approved by Blueprint for an exemption for health reasons contraindicating the vaccines or sincerely held religious beliefs. Accommodation requests for either of these reasons should be made to TotalRewards@blueprintmedicines.com.

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 Poster and its Supplement, as well as our Pay Transparency Statement. 

Blueprint Medicines is a global precision therapy company that invents life-changing therapies for people with cancer and blood disorders. Applying an approach that is both precise and agile, we create medicines that selectively target genetic drivers, with the goal of staying one step ahead across stages of disease. Since 2011, we have leveraged our research platform, including expertise in molecular targeting and world-class drug design capabilities, to rapidly and reproducibly translate science into a broad pipeline of precision therapies. Today, we are delivering approved medicines directly to patients in the United States and Europe, and we are globally advancing multiple programs for systemic mastocytosis, lung cancer and other genomically defined cancers, and cancer immunotherapy. For more information, visit www.BlueprintMedicines.com and follow us on Twitter (@BlueprintMeds) and LinkedIn.