Sorry, this job is no longer accepting applications. See below for more jobs that match what you’re looking for!

Vice President, Pharmacovigilance And Drug Safety

Expired Job

Blueprint Medicines Corporation Cambridge , MA 02139

Posted 9 months ago

At Blueprint Medicines, as our name indicates, we are creating a blueprint for the future of healthcare. We are a leading company in the personalized medicine revolution by focusing on delivering new medicines that are targeted to the genetic driver of disease. We do this by leveraging our one-of-kind drug discovery platform to discover, develop and work to bring highly-selective kinase inhibitors to patients globally. This prolific scientific platform has enabled Blueprint Medicine to build a pipeline of novel therapies that span three distinct areas of medicine; genomically defined cancers, rare diseases and cancer immunotherapy.

Reporting to the CMO, the VP, Pharmacovigilance and Drug Safety will be responsible to develop Blueprint's global pharmacovigilance strategy, for the strategic implementation, execution and management of Pharmacovigilance and risk management activities, and for ensuring compliance with global regulations. He or she must effectively collaborate cross-functionally at all levels in the organization as well as with partners and Health Authorities. He or she must be comfortable evaluating the appropriate balance of risk and benefit according to the characteristics of the clinical indication being studied. The VP Pharmacovigilance and Drug Safety will lead and provide medical oversight for the pharmacovigilance, drug safety and risk management functions for investigational and, if approved, marketed products, ensuring proactive and timely signal detection and risk-benefit assessments. This individual should be a self-starter with excellent leadership and management capabilities who is seeking to be part of an innovative and fast-paced team to support the company's drug development and potentially commercial activities.

Responsibilities:

  • Oversees and directs all aspects of pharmacovigilance and risk management activities for investigational compounds and, if approved, marketed products; actively participates in oversight of patient safety in all clinical trials.

  • Designs, directs and conducts ongoing safety surveillance of company drug products using internal resources and external vendors to ensure delivery of high-quality pharmacovigilance services.

  • Negotiates contracts, interacts and supervises the activities of CROs and consultants for pharmacovigilance services.

  • Organizes and leads regular, cross-functional safety review and signal detection meetings for all investigational and, if approved, marketed drug products, updates senior management on changes in the risk-benefit profile of company drug products, and implements appropriate safety updates and risk mitigation plans.

  • Provides strategic planning, implementation, and management of drug safety activities to support clinical development of the Blueprint pipeline.

  • Provides oversight of all clinical safety activities including review and processing of SAEs and SUSARs, and preparation of case narratives and analyses of similar events.

  • Lead role to respond and resolve safety questions from regulatory authorities, as well as regulatory agency audits and inspections, and corrective action plans.

  • Directs the development, preparation and submission of periodic and annual safety reports (e.g., DSUR, PSUR, periodic line listings, NDA safety updates), and other reports as necessary.

  • Provides medical safety review for all critical documents for clinical development from submissions to initiate first-in-human studies through marketing applications and, if our products are approved, completion of any post-marketing requirements.

  • Ensures departmental budgets and schedules meet corporate requirements.

  • Manages internal staff and external contractors to ensure delivery of quality safety and pharmacovigilance services, including selecting, developing, training, and evaluating team to ensure the efficient operation of the drug safety function.

  • Monitors industry best practices and changes in global safety regulations and guidelines. Recommends changes and upgrades to existing departmental policies, SOPs and systems to ensure global safety regulatory compliance.

  • The role will require some travel (approximately 10-15%), and hiring and managing people.

Qualifications:

  • M.D. or D.O. degree with post-graduate training in a medical specialty is required.

  • Minimum of 15+ years of progressive experience in pharmacovigilance / drug safety in a biotechnology or pharmaceutical company required.

  • Pharmacovigilance experience in oncology or other serious diseases is preferred.

  • Expert knowledge of FDA safety regulations, ICH Guidelines, EU GVP and other applicable regulatory guidance documents; expertise in global safety regulations and reporting requirements.

  • Knowledge of ARGUS or similar relational database applications used for safety reporting.

  • Expertise in clinical safety assessments, safety signal detection and risk management, including interactions with regulatory authorities

Capabilities:

  • Executive gravitas with natural ability to communicate and influence effectively to varied audiences

  • Comfortable and adept at balancing risk and opportunity

  • Ability to manage and prioritize multiple matters simultaneously and to respond to rapidly shifting priorities in ambiguous or challenging situations while leading others through the ambiguity and change

  • Demonstrated ability to solve problems with innovative solutions along with strong organizational skills

  • Possess strong and dynamic leadership skills, with excellent written, verbal and presentation skills

  • Effective team player, who fosters collaboration within and across functional areas

  • Sound strategic evaluation, analysis, and decision-making skills

  • Ability to work in a dynamic, fast paced environment

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

WHO WE ARE:

Blueprint Medicines' mission is to dramatically improve the lives of patients with genomically defined diseases. Our singular focus is to use our deep understanding of the genetic blueprint of cancer and other diseases driven by the abnormal activation of kinases to craft highly selective medicines aimed at eradicating these diseases.

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 does matters and that our success depends on our ability to work together. 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.


See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Director Pharmacovigilance Operations Safety Information And Data Management

Amgen Inc.

Posted 5 days ago

VIEW JOBS 10/16/2018 12:00:00 AM 2019-01-14T00:00 Career CategorySafetyJob Description Amgen is seeking a Director Pharmacovigilance Operations to work out of their Thousand Oaks, CA or Cambridge, MA location. The Director Pharmacovigilance Operations ensure that Pharmacovigilance (PV) Operations Safety Systems and processes fulfill the desired compliance, business process, data integrity, quality, and security objectives globally and cross-functionally. The Director of PV Operations additional responsibilities are: * To ensure the organizational needs for data and PV Operations Safety Systems are met. * Provide technical and managerial leadership to a global team of technical staff ensuring close interaction with the end-user community with the objective of delivering high quality, compliant, validated and timely solutions. * Implementation and management of changes to safety systems. Act as the primary business contact and owner of PV Operations Safety Systems for requirement development, design, implementation and validation of PV Operations Safety Systems, as needed. * Responsible for development, implementation and oversight of processes and procedures relating to effective management of global PV Operations Safety Systems with the objective of maintaining their validated state. This includes providing metrics measuring the efficiency and effectiveness of the team. * Develop robust information and data management strategies. * Work in a highly collaborative manner with team members to understand their needs and translate them into prioritized plans for action. * Provide business oversight and guidance for development and management of information and data management processes and documentation. * Drive the implementation of pharmacovigilance data requirements through cross-functional governance bodies that oversee data exchange with pharmacovigilance systems within remit. * Manage individual and group projects of moderate to high complexity. * Oversee the development and implementation of comprehensive data and PV Operations Safety Systems related training. * Responsible and accountable for timely escalation of issues and concerns that impact PV Operations Safety Systems, collaboration and efficient working of the team to the Head of PV Operations. * Work closely with all functional areas to develop solutions, work plans and oversee their implementation, including but not limited to gathering, business requests for PV Operations Safety Systems, changes and upgrades. Provide subject matter expertise for PV Operations Safety Systems upgrades and changes. * Develop effective relationships with IS and external vendors to ensure successful execution of information and data management strategies within pharmacovigilance systems. * Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness. * Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility. * Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor. Basic Qualifications: Doctorate degree and 4 years of drug safety/PV operations, clinical development, clinical operations experience OR Master's degree and 8 years of drug safety/PV operations, clinical development, clinical operations experience OR Bachelor's degree and 10 years of drug safety/PV operations, clinical development, clinical operations AND 4 years of managerial experience directly managing people and/or leadership experience leading team, projects or programs Preferred Qualifications * 5+ years direct experience supporting successful global Safety databases, data migration, management and/or implementations for large or medium-sized Pharma. * Experience must include reviewing business process and requirements analyses with a strong focus on ensuring customer satisfaction. * Demonstrated knowledge and experience in implementing solutions to meet global Clinical Trial/Pharmacovigilance regulatory requirements in safety systems * Demonstrated ability to manage multiple concurrent projects. * 5+ years strong project management knowledge and experience. * In-depth knowledge of MedDRA and WHODrug coding dictionaries * In-depth knowledge of Clinical Trial and Pharmacovigilance Processes * Understanding of clinical trial Electronic Data Capture (EDC) systems, clinical trial coding systems, and dictionary query management systems * Understanding of Safety systems (ARISg, Argus, or equivalent) * Understanding of software development lifecycle and development standards, including validation methodology * Understanding of global regulations for pharmacovigilance and safety reporting * Experience interacting with regulators during inspections * Understands impact of emerging scientific/technical trends and their implications for Amgen * Experience creating insightful and progressive functional strategy (multi-year) * Problem solving and process improvement/change management experience * Organization, prioritization, planning and measurement of work deliverables * Ability to build relationships and work cross-functionally * Strong communication, collaboration and leadership skills Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. . Amgen Inc. Cambridge MA

Vice President, Pharmacovigilance And Drug Safety

Expired Job

Blueprint Medicines Corporation