PSG Global Solutions Careers
Medical Reviewer/Safety Reviewer II
PSG Global Solutions Careers, Lake Bluff, Illinois, United States, 60044
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Medical Reviewer/Safety Reviewer II , working in
Healthcare Systems and Services
industry in
Lake Bluff, Illinois, United States .
Job description:Participates in applicable safety surveillance activities for assigned products; and in planning and completion of AdHoc Safety Reports as needed.Timely assessment of adverse event coding for consistency and accuracy of coding and accurate and effective medical review of safety related CRFs and labs, including communication with Study Designated Physicians by interfacing with study manager, Clinical Research Organizations, Clinical Research Associates, Data Management, Pharmacovigilance and others to assure query resolution.Supervise tracking of safety related queries to Investigators and assists in handling safety questions from IRB/IEC.Assist with Study Safety Review Plan development and implementation in collaboration with Study Designated Physicians and provides Safety overview to Clinical team members, Clinical Research Organizations, Investigators and investigator sites as needed and review study protocols, IND reports, annual reports, Investigator Brochures, Safety sections of the Clinical Reports, Monitoring Plans, IDMC data and other ad hoc reports which include safety data.Create narratives of serious adverse events and other identified events of interest in accordance with accepted standards and with high degree of competency.Apply knowledge of ICH, FDA, EMA regulations and guidelines affecting drug and disease state, understanding issues to assigned responsibilities with an in depth understanding of product labeling/literature, including safety profile. Understand, implements and improves department SOPs. Clinical knowledge to apply to adverse event data collection and assessment.May serve as a representative for Safety Management on cross functional projects, but does not assume decision making.
Our Client
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
Requirements:
Bachelors degree with related health science background is requiredRN or clinical pharmacy experience strongly preferredMinimum 3 years clinical experience with a minimum of 1 year drug safety/pharma experience (or) 2 years clinical experience with a minimum of 3 years drug safety/pharma experienceProficiency in Computers (Windows, Word, Excel) and in specific databases (e.g., oracle/clinical, PIMS, laboratory databases)Ability to critically evaluate medical dataAbility in accurately and medically presenting; of case data, both orally and in writingAbility to identify, prioritize and assign tasks to others in Clinical Safety Manager's absence
What Do You Think?Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?
Medical Reviewer/Safety Reviewer II , working in
Healthcare Systems and Services
industry in
Lake Bluff, Illinois, United States .
Job description:Participates in applicable safety surveillance activities for assigned products; and in planning and completion of AdHoc Safety Reports as needed.Timely assessment of adverse event coding for consistency and accuracy of coding and accurate and effective medical review of safety related CRFs and labs, including communication with Study Designated Physicians by interfacing with study manager, Clinical Research Organizations, Clinical Research Associates, Data Management, Pharmacovigilance and others to assure query resolution.Supervise tracking of safety related queries to Investigators and assists in handling safety questions from IRB/IEC.Assist with Study Safety Review Plan development and implementation in collaboration with Study Designated Physicians and provides Safety overview to Clinical team members, Clinical Research Organizations, Investigators and investigator sites as needed and review study protocols, IND reports, annual reports, Investigator Brochures, Safety sections of the Clinical Reports, Monitoring Plans, IDMC data and other ad hoc reports which include safety data.Create narratives of serious adverse events and other identified events of interest in accordance with accepted standards and with high degree of competency.Apply knowledge of ICH, FDA, EMA regulations and guidelines affecting drug and disease state, understanding issues to assigned responsibilities with an in depth understanding of product labeling/literature, including safety profile. Understand, implements and improves department SOPs. Clinical knowledge to apply to adverse event data collection and assessment.May serve as a representative for Safety Management on cross functional projects, but does not assume decision making.
Our Client
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
Requirements:
Bachelors degree with related health science background is requiredRN or clinical pharmacy experience strongly preferredMinimum 3 years clinical experience with a minimum of 1 year drug safety/pharma experience (or) 2 years clinical experience with a minimum of 3 years drug safety/pharma experienceProficiency in Computers (Windows, Word, Excel) and in specific databases (e.g., oracle/clinical, PIMS, laboratory databases)Ability to critically evaluate medical dataAbility in accurately and medically presenting; of case data, both orally and in writingAbility to identify, prioritize and assign tasks to others in Clinical Safety Manager's absence
What Do You Think?Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?