Associate/Manager, Drug Safety & Pharmacovigilance Operations
Company: Blueprint Medicines Corporation
Posted on: June 7, 2021
Associate/Manager, Drug Safety and Pharmacovigilance
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
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
- Monitors compliance with regulations, PV agreements and
- 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
- 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
- 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
- Analytical and problem-solving skills with superb attention to
- Must work effectively/collaboratively in a fast-paced team
environment and with individuals at all levels within an
- Proven ability to work within a cross-functional, matrixed
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
Keywords: Blueprint Medicines Corporation, Cambridge , Associate/Manager, Drug Safety & Pharmacovigilance Operations, Other , Cambridge, Massachusetts
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