What are the responsibilities and job description for the Pharmacovigilance Scientist position at Kelly?
- Remote
- Pay: $50/hr
- 6 month contract with the possibility of extension/conversion to perm
This position is responsible for critical activities in support of Signal Management in line with GPSE’s mission to ensure patient safety. This position supports the development, implementation and maintenance of the applications and tracking systems, and helps drive business and operational efficiency. Primary responsibilities include but are not limited to:
- Provides expert project/program management and leadership skills to ensure internal, cross-functional, cross-divisional project plans are in place for the Signal Management Center of Excellence related initiatives.
- Provides project management of the Signal Management processes (e.g., KPIs, metrics, dashboards).
- Supports key initiatives that have cross-functional impact and that are critical to Signal Management business objectives.
- Ensures Signal Management processes meet highest standards by working cross functionally and supporting the development of required processes (e.g., with Global Regulatory Affairs, Quantitative Sciences).
- Promotes interactions with other PV functions including QPPV, Global Medical Safety to ensure processes are regularly updated and are fit for purpose.
- Collaborates with GPSE sub-functions and with partners vendors engaged on Signal Management activities.
ACCOUNTABILITIES:
- Supports projects/initiatives and change-management activities.
- Identify and execute opportunities for infrastructure enhancements and efficiencies, including process improvement.
- Supports interactions with other relevant functional areas both within and outside of global PV to ensure standards are maintained.
- Supports vendor engagement by working with stakeholders to identify and support implementation of opportunities for efficiency gains.
- Utilizes project and program management expertise to drive project teams to achieve clarity on issues and focus on effective contingencies; interface with management and influence decision-making, monitor progress, gaps, risk management to ensure progress and business continuity.
- Assists in the development of processes and job aids as it relates to signal management.
- Any other tasks assigned by manager to assist in departmental activities
- Bachelors required. Post-graduate degree or equivalent (Master’s Degree/MBA) preferred.
- Experience in program and/or project management, preferably in the Pharmaceutical or Biotech industry in clinical development, regulatory affairs, pharmacovigilance, or related function.
- An understanding of and experience in the drug development process, including post-marketing and life-cycle management, with a focus on drug safety/pharmacovigilance.
- Project management abilities and insights required to work productively in a global company and across multiple functions.
- Strong ability to proactively identify areas for process improvement and lead infrastructure-related projects efficiently and within given time constraints.
- Ability to proactively identify and anticipate project risks, including those associated with non-adherence to the regulations, and a keen understanding of when to escalate issues quickly and efficiently.
- Capacity to manage time and priority constraints as well as manage multiple priorities simultaneously
- Excellent time management skills.
- Ability to lead meetings and teleconferences, both internally in Takeda as well as externally to technical groups and vendors.
- Excellent oral and written communication skills.
- Ability to handle confidential information appropriately.
- Excellent presentational skills.
- Excellent level of computer literacy , including EXCEL, MS Project, and Visio.
You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.
Why Kelly®?
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.
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