Kelly Services is currently seeking a remote Pharmacovigilance Scientist to work a contract assignment of 6 months for one of our top clients. Kelly is a full service workforce solutions provider to 98% of the Fortune 100™ companies. We provide employment to more than 700,000 people annually and we deal with some of the largest and best companies both nationally and locally.
Primary Responsibilities of the remote Pharmacovigilance Scientist includes:
Company located in Gaithersburg, MD, but candidate can be fully 100% remote and located anywhere in the country.
- At this company we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe.
- As a Pharmacovigilance Scientist you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. GMD (Global Medicines Development) drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.
- Role will hold a unique position in Respiratory Disease, including asthma, chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF), with a range of differentiated potential medicines in development by leveraging novel combinations, biologics and devices.
- The pipeline also has a number of promising assets in inflammatory and autoimmune diseases within areas such as psoriasis, psoriatic arthritis, gout, systemic lupus and rheumatoid arthritis.
Main Duties and Responsibilities
- As a Pharmacovigilance Scientist you will participate in the triage process for incoming documents to ensure timely and effective medical and scientific evaluation of adverse event information.
- You will request follow-up information from consumers, and health care professionals and requests clarification from foreign affiliates according to specific report types using both global and local SOP timeframes.
- You are responsible to review adverse event documents prepared by the Patient Safety personnel for accuracy, completeness, and validity prior to submission to the FDA. You will lead teams in preparing, organizing, and reviewing tabulations for Regulatory reports.
- You assume responsibility for completing special projects (i.e. IND Annual Reports, PSUR table preparation).
- You support Safety Surveillance, Safety Support - Compliance and Marketing Company and the US Clinical Teams. You serve as a knowledge resource for departmental personnel regarding medical, scientific and Operational issues.
- You are responsible for reflecting the Patient Safety philosophy of being a team player and supports the development of those individuals within the department. You will initiate special projects and demonstrate leadership capabilities at target level or above.
- Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration
- Demonstrated capabilities in: Project management, Time management, Presentation skills,
- Strong attention to detail and organization
- Demonstrated ability to perform with minimal supervision
- Works as a team player and supports the development of other team members
- Excellent knowledge of company policies, procedures and guidelines
- Provides training and mentoring of Patient Safety Coordinators on local and global adverse event reporting and with respect to career development
- Assumes a lead role in identifying Patient Safety related issues and is instrumental in implementing solutions to those issues
- Assumes a lead role in supporting the business unit needs and Patient Safety by actively developing and maintaining partnerships with internal and external customers
- Assumes a lead role in the interview process for prospective new team members
- Demonstrates an active interest in pursuing continuing education within the Pharmaceutical Industry
Essential Education and Experience Requirement of the remote
Pharmacovigilance Scientist includes:
- Bachelor's degree in science / healthcare related field or proven Patient Safety experience equivalence in a similar role with an excellent clinical background. Advanced degree is preferred
- Demonstrated working knowledge of FDA and ICH regulations relevant to Patient Safety and adverse event reporting
- Broad competence with medical, therapeutic and technical terminology
- Able to work effectively as part of a cross functional team
- Excellent verbal and written communication skills
- Contract assignment, duration 6 months.
- Work schedule: full-time, first shift.
Kelly Temporary Employee Perks:
- Group medical, prescription, vision, dental, life, and short-term disability insurance options that are available for purchase—and the coverage is portable*
- Service bonus plan and Holiday pay plan, if qualified
- Weekly electronic pay options
- Free online training campus available
- Exclusive online employee community
- Corporate discounts
This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position you must submit your resume to the Scientific Recruiter listed below:
Please email your resume directly to Sandy at: Sanm174@KellyServices.com [reference BH Job #3400525_sc**]
Thank you for your interest in the assignment.
Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.About Kelly®
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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