Senior Medical Director, Drug Safety & Pharmacovigilance

Company: Blueprint Medicines Corporation
Location: Cambridge
Posted on: January 18, 2025

Job Description:

How will your role help us transform hope into reality?Reporting to the VP and Head of Drug Safety and Pharmacovigilance, the Senior Medical Director (Sr. 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.You 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 as well as closely collaborating with cross functional teams in supporting all clinical development programs, regulatory filling, and global post marketing Safety related activities as relevant. The Sr. MD will also support PV Operations/Safety System teams 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.What will you do?Provide medical safety leadership in clinical studies (e.g., provide strategic input for safety monitoring; proactively evaluate safety data to identify safety signals and ensure timely assessment and communication of safety concerns).Build strong partnership and collaborate with Clinical and other functions during clinical studies. 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).Provide medical safety input in the generation of aggregate safety reports, clinical study reports, etc.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 inspections.Play management/mentorship role as needed.What minimum qualifications do we require? 6+ years' experience as a Medical Safety Lead/Global Safety Officer in clinical trials in the pharmaceutical industry.Medical Doctor degree (MD) from recognized medical school is required. Clinical practice experience is preferred.What additional qualifications will make you a stronger candidate? Proven experience in medical safety assessments, safety surveillance, and risk management activitiesProficiency 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)Good working knowledge of US and EU drug safety and pharmacovigilance regulations, CIOMS and ICH guidelines.Experience in the preparation of responses to regulatory authorities; experience with regulatory filing 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, OptimismWhy 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 ActionAt 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.#LI-Hybrid - #LI-AQ1

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