Job Description
Job Description
Pay rate: 54-64/hr
*depending on range
Medical Review Scientist (nurse)
- 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
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 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 products and patient population (preferred)
Qualifications
- Clinical Nursing qualification and 3 years of related drug safety experience
- Medical Qualification (Nursing Degree); plus 5 years relevant work
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Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available. Planet Pharma
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