Kelly is looking for a Sr. Scientist - Pharmacovigilance to be responsible for core safety deliverables including scheduled and ad hoc aggregate reports and will serve as report owner for assigned reports (medium to large volume, standard complexity).
The Sr. Scientist will have in-depth product knowledge and will support Safety Management Team deliverables as required. Daily activities involve planning, conducting meetings, database searching, aggregate safety analysis and case level review, writing, and project management/coordination of strategic safety documents. The Sr. Scientist will partner with team members, stakeholders including Medical Safety Officers (MSOs), and a vendor.
- Ensure timely, quality reports/safety analyses related to core deliverables with oversight as appropriate
- Collaborate with Therapeutic Area Safety Head (TASH)/MSO/Safety Surveillance Physician (SSP) and other stakeholders on strategy development
- Initiate/Conduct/Oversee searches of internal and external databases
- Perform and/or lead aggregate safety analysis and case level review
- Author, contribute, and coordinate the preparation of core safety deliverables
- Ensure commitments (e.g., Pharmacovigilance Agreements (PVAs), assessment reports) are met
- Partner with vendor to develop reports/deliverables
DECISION-MAKING AND PROBLEM-SOLVING:
- Recognize potential issues and or safety issues and escalate to the attention of the report owner, line manager, or Medical Safety Officer
- Ability to understand nature of adverse drug reactions and complex associations
- High level of flexibility and ability to (re)prioritize work of oneself and others
- Attention to detail and ability to analyze data in broader context
- Ability to work across multiple functions and therapeutic areas
- Review regulatory assessor comments/requests and accommodate/address as appropriate with guidance
EDUCATION & EXPERIENCE REQUIREMENTS:
- Bachelor’s Degree in Health or Biomedical Science (6-8 years industry experience or equivalent)
- Advanced Degree Preferred in Health or Biomedical Science (4-6 years industry experience or equivalent)
- Clinical/Medical writing or PV experience preferred
THIS POSITION COMES WITH ENHANCED BENEFITS WHICH INCLUDE:
50/50 shared healthcare cost (Kelly pays 50% of the monthly premium, employee pays 50%)
Paid sick days and vacation days
•benefits to be received upon meeting eligibility requirements
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume.
As a worker today, it’s up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what’s next is what we’re all about. We know what’s going on in the evolving world of work—just ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.
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. 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.