Clinical Medical Services Specialist III

Supporting development of materials and delivering training in conjunction with the vendor, including train-the-trainer, special-topics, refresher, and internal Client trainings as needed. leadership attributes: Agile and Accountable; Clear and Courageous; Make Possibilities Real; All. for One Client; Decide Smart and Sure.

Bill: $62
Pay: $44-41
Spread:256.7-404.1
Duration:1 yr


100% remote
Looking for RNs with clinical and PV experience
**PharmD candidates are a different skillset and not the type of candidate ideal for this role.
**Nursing background is key. Pharma experience is helpful but not a hard requirement
Job Descprition:
Conducting oversight of vendors to ensure collection, assessment, and processing of adverse
event information (post marketing) is performed in a compliant and timely manner
to comply with global regulations including:
o Seriousness assessment
o Labeling
o Causality
o Initial and Follow-up
Conducting oversight of vendors to ensure company standards for quality, compliance and
productivity are met. Remaining current on knowledge and skills required for case processing.
Supporting vendor case quality, case processing metrics and agility using the Client core
leadership attributes: Agile and Accountable; Clear and Courageous; Make Possibilities Real; All
for One Client; Decide Smart and Sure.
Supporting and participating in audits and inspections as needed.
Developing knowledge and expertise to initiate mentoring of MSA's in vendor management.
Supporting development of materials and delivering training in conjunction with the vendor,
including train-the-trainer, special-topics, refresher, and internal Client trainings as needed.
Other duties may be assigned based on the need or work requirement of the organization
Experience/Skills:
Nursing experience and preferably experience with critical care/ICU/Cardiac/ER. Pharmacovigilance experience preferred.
RNs with clinical and PV experience
o 2-4 years clinical experience or 2-3 years clinical experience and 1-year
pharmacovigilance experience.
o Demonstrates ability to lead project work. Proven success in results-driven process
management.
o Demonstrates ability to work collaboratively in team environment.
o Demonstrates understanding of the changing regulatory environment and impact to case
management process
o Core knowledge of industry regulations (ICH, FDA, EMEA, MHRA).
o Competent in case processing processes, procedures, conventions.
Provides medical support with emphasis on the intake of medical product experiences and processing standard communication requests. Acts as a liaison with Quality Assurance for product quality problems where an adverse event is involved. Works with Customer Service to provide standard information and product replacement as necessary. Provides assistance to the medical and Client community with standard information that is from the package insert or information from the standard letter database that deals with labeled and specific off-label information/indications.

Bussiness Unit:

R&D-Pharmacovigilance and Patient Safety (PPS) (RDPP)

Cost Allocation:

6003|CC|RDI SAFETY OPERATION (615328)