Description
Kelly® Science & Clinical is seeking a Pharmacovigilance Manager for a fulltime, contract position with a top CRO. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Essential Functions:
Serves as a creator/contributor for signal detection and product safety scientist tasks.
• Leads and performs safety signal management activities including detection, validation, prioritization, evaluation, confirmation or refutation, and the tracking of risk mitigation and minimization actions using Oracle Empirica Signal and Topic.
• Performs ongoing review of emerging safety data from various sources including individual case safety reports, published literature, aggregate reports, and other sources.
• Effectively lead, oversee and participate in the planning, preparation and review of periodic safety reports (e.g. DSUR, PSUR, PADER)
• Assist in assessment of medical safety data for assigned products, development and execution of safety signal and benefit-risk management strategies and closely collaborate with stakeholders.
• Participate in the presentation and analysis of safety data from on-going and completed clinical trials and from post-marketing sources.
• Prepare data for and actively participate in safety governance processes.
• As needed, review and provide safety input, for key study-related documents, e.g. protocols, Investigator's Brochure (IB), or Informed Consent Form (ICF)
• Conducts quality review for signal detection and product safety scientist tasks which are low to high in complexity, or which concern low to high complexity products.
• Advises clients on safety related issues.
• Supports training and mentoring of junior colleagues.
• Contributes to development of processes, tools and systems.
• Ensures that tasks are conducted in accordance with company policies and procedures, contractual agreements, and applicable regulations.
• Participates in departmental initiatives; Serves as a subject matter expert in designated area.
• Responsible for routine project implementation and coordination for assigned projects, including leading kick-off meetings, coordination of communications and data requests, participation in client meetings, audits and inspections, and review of metrics and budgets.
• Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
• Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
• Frequent contacts with internal personnel and outside customer representatives.
Education and Experience:
• Bachelor's or Master's degree in pharmacy, nursing, healthcare or other life sciences fields.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10+ years).
• 10 + years Pharmacovigilance experience
• Extensive signal detection and safety risk management experience
Knowledge, Skills and Abilities:
• Expertise in pharmacovigilance requirements relating to marketed products and clinical trials across all major markets
• Extensive signal detection & management experience is a must.
• Understanding of the principles of databases, querying data sources as well as developing and applying search strategies
• Working knowledge of MedDRA
• Excellent attention to detail, data interpretation and medical-scientific writing skills
• Advanced critical thinking and problem-solving skills with ability to evaluate and escalate appropriately Solid project management skills with the ability to manage multiple projects simultaneously and ability to redress issues proactively with limited management intervention
• Ability to motivate, mentor and provide guidance to less experienced staff, routinely exhibiting robust and proactive scientific expertise
• Excellent oral and written English language communication skills, including paraphrasing skills
• Advanced computer skills with the ability to work within multiple systems; advanced skills in Microsoft Office products (including Outlook, Word, and Excel)
• Working knowledge of Oracle Empirica.
• Ability to maintain a positive and professional demeanor in challenging circumstances and to proactively plan for likely scenarios using personal experience
• Ability to work effectively within a team to attain a shared goal
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
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