Medical Director, Drug Safety & Pharmacovigilance

How will your role help us transform hope into reality?

The Medical Director (MD) will be a member of the Medical Safety Team and taking the role of product safety lead on clinical development program(s) and/or post-marketing products. This individual contributor will lead medical assessment and interpretation of safety data from multiple sources including clinical trials, spontaneous and solicited post marketing reports, aggregate, and literature reports. Reporting into Senior Medical Director, Drug Safety and Pharmacovigilance, you will be closely collaborating with cross functional teams in supporting all clinical development programs, regulatory filings, and global post marketing safety related activities. You will also support PV Operations/Safety System teams in the oversight of PV service vendors and partners and will need to maintain medical knowledge, as well as current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk-management practices.

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What will you do?

• Provide medical safety input and participate in safety surveillance activities (e.g., identification of safety signals and ensure timely assessment and communication of confirmed safety signals).
• Provide input in the generation of aggregate safety reports (e.g., DSURs, PADER, PBRER).
• Serve as a leading medical safety resource for the development and review of clinical trial protocols, informed consent forms (ICFs), investigator brochures (IBs) and Reference Safety Information (RSI).
• Collaborate with medical monitors, clinical research scientists, and vendor clinical staff as needed for ongoing clinical trials.
• Provide medical safety input in the development and/or updates of risk management plans and the maintenance of these documents.
• Provide support and input to the development of standard operating procedures, working instructions, and other guidance documents.
• Serve as a subject matter expert for vendors that provide drug safety and pharmacovigilance services.
• Work closely with other product safety leads to respond to and resolve safety questions from health authorities as well as regulatory agency’s audits and inspections.
• Provide medical expertise in the assessment of ICSRs and aggregate safety data.
• Provide mentorship as needed.

What minimum qualifications do we require?

• 3+ years of experience as a product safety lead 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?

• Good working knowledge of US and EU drug safety and pharmacovigilance regulations, CIOMS, and ICH guidelines
• Proven experience in medical safety assessments, safety surveillance and risk management 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 preparation of aggregate reports (e.g., DSUR, PSUR/PBRER, PADER)
• Experience in preparation of responses to regulatory authorities; experience with regulatory filling and related activities preferred
• Experience with the development and updates to Reference Safety Information, Company Core Data Sheet (CCDS) and product labels
• Ability to collaborate and influence across functional areas within the company and with 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?

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 [email protected]. 

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.

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