Planet Pharma
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Sr. Global Safety Medical Scientist
role at
Planet Pharma .
2 days ago Be among the first 25 applicants.
Job 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 assessments 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 the representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility.
Job Details
Target PR Range: $60-70/hr depending on experience.
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 safety systems including the Safety database and medical coding.
Knowledge of safety data capture in clinical trials and post-marketing environments.
Knowledge of clinical trials and drug development.
Knowledge of products and patient populations.
Basic Qualifications Medical Qualification: MD/DO or international equivalent plus 3 years relevant work experience. CO/NYC candidates might not be considered.
Additional Information The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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Sr. Global Safety Medical Scientist
role at
Planet Pharma .
2 days ago Be among the first 25 applicants.
Job 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 assessments 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 the representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility.
Job Details
Target PR Range: $60-70/hr depending on experience.
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 safety systems including the Safety database and medical coding.
Knowledge of safety data capture in clinical trials and post-marketing environments.
Knowledge of clinical trials and drug development.
Knowledge of products and patient populations.
Basic Qualifications Medical Qualification: MD/DO or international equivalent plus 3 years relevant work experience. CO/NYC candidates might not be considered.
Additional Information The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
#J-18808-Ljbffr