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Global Safety Senior Medical Scientist
Remote, CA US
Posted: 06/06/2025
2025-06-06
2025-07-12
Employment Type:
Contract
Job Category: Scientific
Job Number: 4468
Job Description
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 autolabel 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
- Medical Qualification: MD/DO or international equivalent plus 3 years relevant work
- 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 capture in clinical trials and in the post marketing environments
- Knowledge of clinical trials and drug development
- Knowledge of products and patient population