Overview
Remote
On Site
Hybrid
$60.6 - $66.64 hr
Contract - Independent
Contract - W2
Contract - 12+ mo(s)
Skills
DOCTOR OF MEDICINE
MD
DOCTOR OF OSTEOPATHIC MEDICINE
DO
MEDICAL
REVIEW
CLINICAL
SAFETY
ICSRS
ICSR
PHARMACOVIGILANCE
PV
CODING
DRUG
PATIENT
THERAPEUTIC
Job Details
Payrate: $60.60 - $66.64/hr.
Responsibilities:
Knowledge and skills:
Basic qualifications:
Top 3 Must Have Skill Sets:
Pay Transparency: The typical base pay for this role across the U.S. is: $60.60 - $66.64/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy ( policy).
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human based decision making in employment decisions. By applying for this position, you agree to Aditi s use of AI technology, including calls from an AI Voice Recruiter.
#AditiConsulting
Responsibilities:
- Execute the medical review of ICSRs (narratives, coding, expectedness, causality, and seriousness) to ensure quality reports. Produce medically accurate ICSRs reports
- Act as MSRT product lead and/or therapeutic area lead
- Execute ICSR case escalation to GSO as appropriate
- Execute appropriate case follow up per SOPs * Support medical coding conventions, and systematic process improvements for ICSR medical review
- Conduct reportability assessment for medical device associated events and/or product complaint associated events, and review for potential product problems.
- Maintain list of expected terms in the auto label tool
- Monitor the compliance of auto label tool updates (if applicable)
- Support and lead Quality Assurance of ICSR medical review (if applicable)
- Support and lead activities for the development, training on and implementation of new processes in MSRT (if applicable)
- Provide training to employees and vendor staff (if applicable) on ICSR medical review
- Participate in Safety Assessment Team (SAT) if applicable
- Perform other duties related to the position as necessary as defined in SOPs or as requested by his/her supervisor
- Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
- Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
Knowledge and skills:
- Knowledge of case management and medical review SOPs and regulatory requirements for Pharmacovigilance
- Clinical knowledge of therapeutic area patient populations and drug class
- Proficiency in technical safety systems including the Safety database and medical coding
- Knowledge of safety data captured in clinical trials and in the post marketing environments
- Knowledge of clinical trials and drug development
- Knowledge of products and patient population
Basic qualifications:
- Medical Qualification: MD/DO or international equivalent plus 3 years relevant work
Top 3 Must Have Skill Sets:
- Clinical knowledge of therapeutic area patient populations and drug class
- Proficiency in technical safety systems including the Safety database and medical coding
- Knowledge of safety data captured in clinical trials and in the post marketing environments
- Knowledge of clinical trials and drug development
Pay Transparency: The typical base pay for this role across the U.S. is: $60.60 - $66.64/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy ( policy).
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human based decision making in employment decisions. By applying for this position, you agree to Aditi s use of AI technology, including calls from an AI Voice Recruiter.
#AditiConsulting
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.