Senior Medical Director, Drug Safety and Pharmacovigilance

Senior Medical Director, Drug Safety and Pharmacovigilance

Cambridge, MA

Requisition Number: 269

Blueprint Medicines is a global precision therapy company that invents life-changing therapies for people with cancer and hematologic 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 genomically defined cancers, systemic mastocytosis, and cancer immunotherapy.

What will you do?

The Senior Medical Director 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 is an individual contributor role.

This individual is to lead medical assessment and interpretation of safety data from multiple sources, including clinical trials, spontaneous and solicited postmarketing reports, aggregate, and literature reports. The individual will be closely collaborating with cross functional teams in supporting all clinical development programs, regulatory filling, and global post marketing Safety related activities. This individual 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.

This role will report to the VP and Head of Drug Safety and Pharmacovigilance.

What will be your responsibilities?

• 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 and 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 mentorship role as needed.

What basic qualifications do we require?

• 6 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 are we seeking? 

• 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.

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 we require all employees to be fully vaccinated against COVID-19, unless we approve an exemption through a reasonable accommodation for certified health reasons 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 who requires an accommodation with the hiring process or to perform any essential functions of the position for which you are applying, 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. 

Who we are:

We don’t think in small steps. We think in giant leaps.

We are driven by the pursuit of new ideas, new innovations, and new ways of thinking.

We know that what each and every one of us matters and that our success depends on our ability to work together in a diverse community.  We believe we are at our best as a company when our employees are thriving and we foster a culture that provides opportunities to grow and develop professionally, while also having fun.