Associate/Medical Director, Drug Safety & Pharmacovigilance
Cambridge, MA 
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Job Description

Associate/Medical Director, Drug Safety & Pharmacovigilance

Cambridge, MA

Requisition Number: PV21-903

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?

Reporting to the Senior Medical Director, Drug Safety and Pharmacovigilance, the Associate/Medical Director will work as a member of the Medical Safety Team within DSPV and Medical Safety Lead for one or more Blueprint products in clinical development and/or in the post-market setting. This individual will be responsible for assessing and interpreting safety data from multiple sources, including clinical trials, spontaneous and solicited reports, and literature reports. This physician is expected to provide interpretation and summaries information and provide input in the generation of safety reports (e.g., DSURs, PSUR and clinical safety assessments). This person will be an integral part of a group of safety professionals and collaborate with members of cross-functional teams as well as safety teams in Contract Research Organizations (CROs) and partners. They will need to maintain medical knowledge as required by the role, strong and current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk-management practices.

What will be your responsibilities?

  • Provide medical expertise in the assessment of ICSRs and aggregate safety data.
  • Work closely with PV Scientist(s) in safety surveillance and signal detection activities to ensure timely assessment and communication of confirmed safety signals.
  • Provide medical input in the generation and review of aggregate safety reports (e.g., development safety update reports, periodic benefit risk evaluation reports).
  • Provide expertise on the creation or updates to Risk Management Plans (RMPs).
  • Support clinical development program(s) for the generation and review of clinical trial protocols, informed consent forms (ICFs) and investigator brochures (IBs) and other documents as needed (e.g., NDA/MAA filing documents).
  • Support internal PV Operations function.
  • Provide expertise on development of Standard Operating Procedures, Working Instructions and other guidance documents.
  • Contribute to safety and pharmacovigilance training programs
  • Provide safety training at investigator meetings as required
  • Collaborate with Regulatory Affairs to ensure appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies and prescriber community as required.
  • Serve as SME for vendors providing drug safety and pharmacovigilance services.

What qualifications do we require?

  • 2+ 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 capabilities do you bring?

  • Proven understanding of US and EU drug safety regulations, CIOMS and ICH guidelines
  • Proven experience with medical drug safety assessments, drug safety surveillance and monitoring activities
  • Proficiency with medical review of ICSRs, including expectedness assessments, causality assessments, narrative review and generation, 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 literature, solicited and post-marketing environment)
  • Experience with the medical review and preparation of aggregate reports (DSUR, PSUR/PBRER, PADER)
  • Experience with preparation of responses to Regulatory Authorities, preferred experience with IND/NDA submissions and negotiations with Regulatory Authorities as part of marketing approval
  • Experience with the development and updates to Reference Safety Information, including IB, Company Core Data Sheet (CCDS) and local labels
  • Ability to build relationships, collaborate and influence across functions within Blueprint Medicines and with partners
  • Experience with MedDRA coding, Points to Consider, AoSE, and SMQs
  • Excellent verbal, written and presentation skills

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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 foster a culture that provides opportunities to grow and develop professionally, while also having fun.

 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Experience
2+ years
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