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Associate/Manager, Drug Safety & Pharmacovigilance Operations

Company: Blueprint Medicines Corporation
Location: Cambridge
Posted on: June 7, 2021

Job Description:

Associate/Manager, Drug Safety and Pharmacovigilance Operations

Cambridge, MA

Requisition Number: PV21-003

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 Sr Manager/Associate Director/Director of Drug Safety and Pharmacovigilance Operations, the Sr Associate/Manager of Drug Safety and Pharmacovigilance Operations (DSPV) will play a key role in drug safety operations across the clinical development programs. The Sr Associate/Manager DSPV contributes to the day-to-day operational activities of the department and ensures that performed tasks comply with DSPV SOPs and policies, best industry standards and applicable regulations.

What will be your responsibilities?

  • Participates in the daily management and execution of DS and PV operations.
  • Monitors compliance with regulations, PV agreements and internal SOPs.
  • Represents Drug Safety and Pharmacovigilance on clinical development teams, as assigned.
  • Provides sponsor oversight of SAE processing by outsourced vendors, including the review and monitoring of compliance through various monitoring reports and other oversight activities and ensures the implementation of effective corrective and preventative action plans.
  • Processes SAEs including case triage, data entry, coding review and narrative writing.
  • Provides safety operations support for external submissions, signal detection and risk management planning activities.
  • Ensures compliant exchange of safety data between Blueprint Medicines and its partners.
  • Participates in the quality management system in Drug Safety including ensuring department standards are met, including training requirements, monitoring performance, implementing continuous improvement actions and good documentation practices.
  • Works with QA department to maintain a state of high PV inspection readiness across all regions/countries.
  • Collaborates with contract service providers for case processing, aggregate reporting and quality management activities.
  • Performance management of PV systems.
  • Participates in regulatory inspections and company audits including MHRA/EMA PV inspections; prepares responses to audit findings that concern the DSPV department.

What qualifications do we require?

  • Bachelor's degree in nursing, pharmacy, or other health care related profession or life sciences preferred.
  • Minimum of 1-2 years of experience in a pharmaceutical industry setting or the equivalent. For Manager, 3-5 years of proven experience in pharmaceutical industry setting or equivalent.
  • Safety database, MedDRA coding and data entry experience.
  • Knowledge of FDA and EU legislation and ICH Efficacy guidelines.
  • Analytical and problem-solving skills with superb attention to detail.
  • Must work effectively/collaboratively in a fast-paced team environment and with individuals at all levels within an organization.
  • Proven ability to work within a cross-functional, matrixed team.

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.

Keywords: Blueprint Medicines Corporation, Cambridge , Associate/Manager, Drug Safety & Pharmacovigilance Operations, Other , Cambridge, Massachusetts

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