Do you have expertise in evaluating safety signals from aggregate medical data? Do you love preparing clinical safety assessments and regulatory reports/submissions? Are you are adept at presenting clinical safety data to major global health authorities?
We are looking for high-energy, dedicated leaders who enjoy a challenge, thrive in the details and flourish in dynamic environments. If you are no stranger to taking charge and collaborating to deliver extraordinary work, we have an opportunity for you to lead our global drug safety group.
At Precision for Medicine, we believe that the era of one-size-fits-all medication is giving way to a next generation of treatments, medicines that will be more effective because they are prescribed according to the unique biology of an individual patient. Our mission is to help innovative biotech and pharmaceutical companies accelerate the development of these life-changing treatments. Precision does this by developing assays that utilize biomarkers to help identify the right patient for the right drug. We also handle every aspect of clinical trials from initial strategy and design to selecting sites and managing trial data.
Enough about us, let's talk about you for a while.
* You are a strong leader with strategic vision and drive to contribute.
* You are passionate about collaborating with a team of professionals who are driven to get things done and committed to drug safety.
* You are a self-starter with internal motivation that amazes colleagues.
* You flourish and thrive in fast-paced environments and are a master multitasker.
* You love mentoring, motivating, and fostering teamwork.
* You are a natural problem-solver who enjoys when no day is the same.
* Handling conflict and negotiations comes easily to you.
If this sounds like you, then we believe your dream job is waiting.
What your day to day will look like:
As the Vice President, Global Drug Safety you will serve as a senior drug safety expert responsible for the safety strategy and oversight for the organization. You will lead a global team of safety professionals and will maintain strong and current knowledge of drug safety and pharmacovigilance (PVG) regulations, PVG practices and surveillance, and risk-management practices. You will provide oversight for safety data surveillance and interpretation from multiple sources including clinical trials, spontaneous and solicited reports, and literature reports.
* Lead an efficient and successful global PVG organization.
* Deliver high quality, timely and standardized PVG deliverables.
* Provide content mentorship and functional approval for all safety documentation.
* Establish and maintain common global processes and guidelines for PVG assessment, analysis, and compliance, including documented guidance for coding and the assessment of causality/expectedness for adverse event reports, as required.
* Ensure that aggregate data safety signals are identified promptly and communicated appropriately, including oversight of use of signal detection tools and other sources for potential product signals.
* Initiate and maintain productive cross-functional collaborations.
* Collaborate with the business development team regarding direction for business development plan/strategy.
* Represent drug safety at sponsor audits and regulatory body inspections when needed.
* Manage finances (profit and loss) and growth of the department.
* Improve scientific and clinical experience of staff through continuous training and mentoring.
* Prepare departmental objectives and evaluate and handle performance of the Safety team.
* Medical degree (M.D, D.O, MBBS, or equivalent)
* At least 12 years of experience in the CRO/Pharmaceutical industry focused on pharmacovigilance
* Management experience with oversight of medical safety activities and leading pharmacovigilance teams in pharmaceutical development
* Ability to travel up to 20% domestically and internationally including overnight stays
* Experience in oncology and/or rare disease
Precision for Medicine supports life sciences companies in the use of biomarkers essential to targeting patient treatments more precisely and effectively. Precision applies novel biomarker approaches to clinical research that take advantage of the latest advancements in science and technology, focusing predominantly on genomics, immune-response assays, global specimen logistics, biomarker analytics, companion diagnostics, and clinical trial execution. Precision for Medicine is part of Precision Medicine Group, with nearly 2,000 employees in 34 locations in the US, Canada, and Europe.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. ? 2018 Precision Medicine Group, LLC
Associated topics: lab, medical, medical lab science, medical laboratory science, medical technologist, microbiology, mlt, sample collection, services, technician ii
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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