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 6 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.


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
Senior Medical Director Dru...

Akebia Therapeutics, Inc.

Posted Yesterday

VIEW JOBS 7/22/2018 12:00:00 AM 2018-10-20T00:00 Reporting to the Head DSPV, the Senior Medical Director of Drug Safety & Pharmacovigilance is responsible for the management, analysis and interpretation of safety data. The role will build and lead a safety function that will oversee safety across various compounds in clinical development. He/she will provide key leadership to best support innovative, critical, and strategic review of clinical safety data, and its appropriate positioning. Fundamental to this position will be seamless cross functional working, particularly in support of developmental and submission activities. The position will lead a group of safety professionals who, in addition to internal responsibilities, input and oversee work undertaken externally. There is a requirement for close familiarity with global regulatory requirements, particularly impacting developmental programs. The initial focus of responsibilities will be strongly focused on supporting global compound submission activities. Required Skills * Provide strategic direction for proactive safety surveillance, aggregate data analysis and risk management for developmental (and ultimately) marketed) compounds * Seamless cross-functional working to support fully inclusive compound stewardship for developmental and (ultimately) marketed compounds * Provide safety and Pharmacovigilance (PV) expertise in-house and via external vendors for all development programs * Be accountable for identification, assessment and communication of potential safety signals * Provide oversight and key input for review of new or on-going safety documents in compliance with international regulatory requirements * Generate and analyze trend analysis reports and appropriate signaling conclusions * Support timely reporting of safety information to regulatory agencies and prescriber community in close collaboration with regulatory colleagues * Input into the development of SOPs for PV and drug safety monitoring * Oversee preparation and quality control activities for key safety documents * Provide key input in review and finalization of clinical protocols and other study-related documents, as needed * Collaborate with Medical Directors, Clinical Research Scientists, and vendor clinical staff to support medical monitoring for ongoing clinical trials * Develop relationships with and capture drug safety information from key groups, including partner companies, physicians, nurses and patient advocacy groups * Provide input for potential in-licensing opportunities and Pharmacovigilance agreements with commercial and alliance partners * Senior oversight of safety vendor responsible for generation of aggregate safety reports which include PSURs and DSURs * Draft section(s) of the initial Risk Management Plan (RMP) and/or Risk Evaluation and Mitigation Strategies (REMS) for assigned products, and oversee the maintenance of these documents. Provide input into the preparation and coordination of assigned aggregate reports as appropriate (i.e., DSUR, IND annual report, NDA annual report Periodic Benefit Risk Evaluation Report (PBRER) for marketed products, etc.) * Closely work with VP DSPV to support strategic planning and resource assessments * Support and manage pharmaco-epidemiologic interpretation of safety data; including utilization of data-mining tools * Provide training and mentorship to physicians and scientists re safety surveillance and risk management training cross functionally * Anticipate regulatory implications of emerging safety issues and develop responsive strategies cross functionally, including labelling * Support internal and external audits/inspections as required * Close alignment with Akebia business needs in a fast-evolving environment, within the primacy of patient safety * Maintain professional knowledge via continuing medical education Required Experience * 10+ years of experience in Drug Safety/Pharmacovigilance in a pharma/biotech/CRO * Medical Degree (MD or equivalent) required * Demonstrated leadership capabilities, including line management responsibilities, effective cross-organizational skills, and proven track record building teams and mentoring individuals * Ability to build relationships and influence across disciplines * Experience with MedDRA or similar coding and safety database systems * Excellent verbal, written and presentation skills * Intellectual dexterity and adaptive mindset Job LocationCambridge, Massachusetts, United StatesPosition TypeFull-Time/Regular Apply Akebia Therapeutics, Inc. Cambridge MA

Vice President, Pharmacovigilance And Drug Safety

Expired Job

Blueprint Medicines Corporation