Job Description
Our Client, a Biopharmaceutical company, is looking for a Medical Safety Reviewer for their Thousand Oaks, CA/Remote location.
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 as assigned
- Execute ICSR case escalation as appropriate
- Execute appropriate case follow up per SOPs
- Support medical coding conventions, and systematic process improvements for ICSR medical review
- Maintain list of expected terms in the auto label tool
- Support Quality Assurance of ICSR medical review
- Participate in Safety Assessment Team (SAT) (if applicable)
- Conduct reportability assessment for medical device associated events and /or product complaint associated events, and review for potential product problems
- Provide input on teams for interdepartmental and cross-functional initiatives (if applicable)
- Perform other duties related to the position as necessary as defined in SOPs or as requested by his/her supervisor
- Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. Produce medically accurate ICSRs reports
- 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
Requirements: - Knowledge of client 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 Safety Database and medical coding
- Knowledge of safety data capture in Clinical Trials and Post Marketing setting
- Knowledge of clinical trials and drug development
- Knowledge of client products and patient population (preferred)
- Clinical Nursing qualification and 3 years of related drug safety experience
- Medical Qualification (Nursing Degree); plus 5 years relevant work
- Clinical Nursing qualification and 1 year of related drug safety experience Medical Qualification (Nursing Degree); plus 3 years relevant work
- Medical review of ICSRs (narratives, coding, expectedness, causality and seriousness), Quality Assurance of ICSR medical review
- Clinical knowledge of therapeutic area patient populations and drug class
Why Should You Apply? - Health Benefits
- Referral Program
- Excellent growth and advancement opportunities
As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws. Iconma LLC
Job Tags
Local area, Remote job,