Medical Safety Reviewer
Spectraforce
Thousand Oaks, California
2 days ago
Job Description
Job Title: Medical Review Scientist (nurse)
Location: Remote or local to USTO is preferrable
Duration: 17+ Months
Day to Day 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
Inspection Readiness:
• 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
Top 3 Must Have Skills:
• 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
Knowledge and Skills:
• 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)
Basic Qualifications
• Clinical Nursing qualification and 1 year of related drug safety experience
• Medical Qualification (Nursing Degree); plus 3 years relevant work
Possible Extension: Yes
Red Flags: NA
Interview Process: One interview web based
About Us: SPECTRAFORCE is one of the fastest-growing workforce solutions firms in the United States. As a diversity-owned business, we place human connection at the heart of everything we do, building strong relationships with both clients and candidates to fill roles successfully. Our teams in North and Central America and India serve more than 150 Fortune clients globally, leveraging custom AI technology to provide direct hire, executive search, nearshoring, offshoring, and project staffing solutions.
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $52.75/hr.
Location: Remote or local to USTO is preferrable
Duration: 17+ Months
Day to Day 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
Inspection Readiness:
• 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
Top 3 Must Have Skills:
• 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
Knowledge and Skills:
• 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)
Basic Qualifications
• Clinical Nursing qualification and 1 year of related drug safety experience
• Medical Qualification (Nursing Degree); plus 3 years relevant work
Possible Extension: Yes
Red Flags: NA
Interview Process: One interview web based
About Us: SPECTRAFORCE is one of the fastest-growing workforce solutions firms in the United States. As a diversity-owned business, we place human connection at the heart of everything we do, building strong relationships with both clients and candidates to fill roles successfully. Our teams in North and Central America and India serve more than 150 Fortune clients globally, leveraging custom AI technology to provide direct hire, executive search, nearshoring, offshoring, and project staffing solutions.
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $52.75/hr.