Pharmacovigilance Scientist II
Location: Remote based but should be local to one of the following sites Titusville, NJ, Raritan, NJ or Horsham, PA
Kelly is currently seeking a Pharmacovigilance Scientist II to support one of the largest pharma companies in the world. This role is offering our enhanced benefit package options. As a Kelly employee within this group, you will be eligible for Medical, Dental, 401K and a variety of other benefits options to choose from. This includes paid time off, including holiday, vacation, and sick/personal time unless told otherwise.
The Sr. Scientist will 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 (SMT) 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
- Provide SMT support as needed
- Act as ad hoc member for assigned products as appropriate
- Training/Meetings/Department initiatives
- Participate in cross-functional training of relevant stakeholders
- Attend departmental meetings and trainings
- Participate in department and/or cross-functional initiatives (15% of the time)
- Recognize potential issues and or safety issues and escalate to the attention of the report owner, line manager, or MSO
- 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
- 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
- Strong verbal and written communication skills
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.
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.