Klein Hersh International
Head of Drug Safety
Klein Hersh International, Oklahoma City, Oklahoma, United States,
Our Client is redefining the power of small molecules to control the expression of genes. Based on its unique ability to elucidate regulatory regions of the genome, our Client aims to develop medicines that provide a profound benefit for patients with diseases that have eluded other genomics-based approaches.
Reporting to the Chief Medical Officer, the Head of Drug Safety will be responsible for leading the pharmacovigilance function, providing leadership and clinical support to drug safety data management and interpretation and risk management activities for the company, including oversight of clinical trial Serious Adverse Event (SAE) processing and safety data analysis to support signal detection and risk/benefit profile evaluation. This individual will ensure timely, consistent, and accurate safety reporting in accordance with FDA, EMA, and ICH guidelines, applicable regulatory requirements, Good Clinical Practice (GCP) and standard operating procedures (SOPs).
Job ResponsibilitiesManage all aspects of Drug Safety and Pharmacovigilance, including leadership of safety data review, signal detection, risk communication including safety information updates, and mitigation of potential risksProvide medical and drug safety expertise to enable decision-making based on ongoing risk-benefit assessment, clinical trial data interpretation, and medical review of individual case reports of serious adverse eventsAddress safety-related topics as a member of the Clinical Leadership TeamWork with Medical Directors, CRO Safety Physicians, and Clinical Scientists on safety monitoring and assessment activities, including:
Providing input for responses to regulatory agency questions and questions from IRBs and Ethics Committees, with respect to safety/pharmacovigilance activities and safety dataActing as the point of contact accountable for setting up and running DSMBsInvestigator’s Brochure/informed consent updatesSetting up and acting as chair for safety data review meetingsParticipating in routine safety cohort reviews for ongoing phase 1 dose escalation studiesEvent coding and database reconciliation
Oversee and manage a growing Safety Operations team, supporting the recruitment, training and professional development of Safety Department personnelConstant evaluation of the effectiveness of the Drug Safety systemCommunicate recommended changes to Drug Safety system changes to assure:
Compliance with safety data management and reporting requirements in all relevant territoriesOptimized safety database ownership and access for safety monitoring, signal detection and reportingEffective SOPs are in placeStrong safety vendor governance
Proactively recommend and plan for future development of Drug Safety and Pharmacovigilance to enable regulatory filings and commercialization, including acquiring QPPV support and the participation in creating Risk Management Plans and a Pharmacovigilance System Master FileOversee drug safety and pharmacovigilance activities conducted in partnership with external business partners or outsourced to vendors and contract research organizationsLead the development of and review DSURs with Medical Directors/Clinical ScientistsReview safety sections on cross-functional documents, including study protocols, study reports, and regulatory reportsEnsure audit and inspection readiness of the function at all times
Job RequirementsMD requiredMinimum of 7 years in Drug Safety related activities in pharma/biotech preferredDemonstrated leadership abilities or oversight rolesClinical trial experienceExperience authoring, reviewing, and providing input to drug-safety related regulatory reportsSuccessful involvement in regulatory agency interactions or inspectionsGood knowledge of FDA, EU, ICH and other global regulatory requirements for safety reporting and safety data and risk managementMedical knowledge and familiarity with medical concepts and terminology used in hematology/oncology clinical trials and safety monitoring highly desirable and strongly preferredComputer knowledge, including Microsoft Office, Windows, and familiarity with safety database useExcellence in oral and written communications with attention to detailAbility to multi-task in a fast-paced environmentPossesses a sense of urgency and an ability to anticipate and respond quickly to emerging informationExcellent oral and written communication skills for effectively interfacing with vendors and internal stakeholdersFosters strong relationships and values collaboration to develop and execute on plansExcellent attention to detail and problem-solving skillsActs with integrity and respect always
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Reporting to the Chief Medical Officer, the Head of Drug Safety will be responsible for leading the pharmacovigilance function, providing leadership and clinical support to drug safety data management and interpretation and risk management activities for the company, including oversight of clinical trial Serious Adverse Event (SAE) processing and safety data analysis to support signal detection and risk/benefit profile evaluation. This individual will ensure timely, consistent, and accurate safety reporting in accordance with FDA, EMA, and ICH guidelines, applicable regulatory requirements, Good Clinical Practice (GCP) and standard operating procedures (SOPs).
Job ResponsibilitiesManage all aspects of Drug Safety and Pharmacovigilance, including leadership of safety data review, signal detection, risk communication including safety information updates, and mitigation of potential risksProvide medical and drug safety expertise to enable decision-making based on ongoing risk-benefit assessment, clinical trial data interpretation, and medical review of individual case reports of serious adverse eventsAddress safety-related topics as a member of the Clinical Leadership TeamWork with Medical Directors, CRO Safety Physicians, and Clinical Scientists on safety monitoring and assessment activities, including:
Providing input for responses to regulatory agency questions and questions from IRBs and Ethics Committees, with respect to safety/pharmacovigilance activities and safety dataActing as the point of contact accountable for setting up and running DSMBsInvestigator’s Brochure/informed consent updatesSetting up and acting as chair for safety data review meetingsParticipating in routine safety cohort reviews for ongoing phase 1 dose escalation studiesEvent coding and database reconciliation
Oversee and manage a growing Safety Operations team, supporting the recruitment, training and professional development of Safety Department personnelConstant evaluation of the effectiveness of the Drug Safety systemCommunicate recommended changes to Drug Safety system changes to assure:
Compliance with safety data management and reporting requirements in all relevant territoriesOptimized safety database ownership and access for safety monitoring, signal detection and reportingEffective SOPs are in placeStrong safety vendor governance
Proactively recommend and plan for future development of Drug Safety and Pharmacovigilance to enable regulatory filings and commercialization, including acquiring QPPV support and the participation in creating Risk Management Plans and a Pharmacovigilance System Master FileOversee drug safety and pharmacovigilance activities conducted in partnership with external business partners or outsourced to vendors and contract research organizationsLead the development of and review DSURs with Medical Directors/Clinical ScientistsReview safety sections on cross-functional documents, including study protocols, study reports, and regulatory reportsEnsure audit and inspection readiness of the function at all times
Job RequirementsMD requiredMinimum of 7 years in Drug Safety related activities in pharma/biotech preferredDemonstrated leadership abilities or oversight rolesClinical trial experienceExperience authoring, reviewing, and providing input to drug-safety related regulatory reportsSuccessful involvement in regulatory agency interactions or inspectionsGood knowledge of FDA, EU, ICH and other global regulatory requirements for safety reporting and safety data and risk managementMedical knowledge and familiarity with medical concepts and terminology used in hematology/oncology clinical trials and safety monitoring highly desirable and strongly preferredComputer knowledge, including Microsoft Office, Windows, and familiarity with safety database useExcellence in oral and written communications with attention to detailAbility to multi-task in a fast-paced environmentPossesses a sense of urgency and an ability to anticipate and respond quickly to emerging informationExcellent oral and written communication skills for effectively interfacing with vendors and internal stakeholdersFosters strong relationships and values collaboration to develop and execute on plansExcellent attention to detail and problem-solving skillsActs with integrity and respect always
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