United Therapeutics
Associate Director, Postmarketing PV Case Management
United Therapeutics, Columbia, South Carolina, us, 29228
United Therapeutics Associate Director, Postmarketing PV Case Management Columbia, South Carolina Apply Now
The job details are as follows:
Take the next step in your career now, scroll down to read the full role description and make your application. What We Do We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal, we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation. Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of "medicines for life". We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases. How you’ll contribute The Associate Global PV Case Management Director plays a key role in management and oversight of end-to-end case safety management activities spanning across our global commercial product portfolio. This position strategizes and implements plans to ensure compliance with global regulations and guidelines regarding safety data collection, management, and reporting for postmarketing ICSRs for efficiency, quality, and compliance impacts. This role is critical in ensuring that commercial operational aspects of pharmacovigilance activities are managed with rigorous global standards in proper documentation, evaluation processes, and decisions to support the overall global safety surveillance program and proper management of benefit/risk of UTC products. This position can be remote in the continental US, or in our RTP, NC office and will include about 15% international and domestic travel. Key Responsibilities: Process Evaluation and Strategy:
Evaluate, strategize, and execute process changes in response to regulatory updates, ensuring the effectiveness and efficiency of end-to-end commercial case processing; Initiate, plan, coordinate, and implement project plans to enhance process efficiencies and support business goals and objectives. Operational Oversight and Quality Assurance:
Oversee day-to-day quality and compliance for vendor staff supporting adverse effect processing for commercial UT products, including PM GSD workflows; Maintain unified PM Case Management operating procedures and monitor systems to ensure all PM adverse effects are processed and submitted per UT SOPs and industry standards. Regulatory Compliance and Guidance:
Provide strategic guidance to ensure compliance with global regulations and guidelines for safety data collection, management, and reporting of postmarketing ICSRs. Stakeholder and Vendor Management:
Act as the main point of contact and functional manager for day-to-day questions or issue escalation regarding PM case handling safety processes for internal stakeholders, vendors, and external partners. Training and Development:
Develop, facilitate, and provide training and training materials for AE, PC, and/or SRS collection and reporting of adverse effects in the commercial setting. Inspection and Audit Management:
Act as the point of contact for inspections and audits related to end-to-end case processing activities for PM case types. SOP and Procedural Document Management:
Initiate and lead the development and implementation of new or revised SOPs; Update and maintain procedural documents to reflect current practice related to GPS/PV Operations. Reconciliation and Compliance Oversight:
Oversee and resolve the PM reconciliation process, ensuring all discrepancies are addressed and compliance is maintained. Perform other duties as assigned. For this role you will need: Bachelor’s degree in nursing, chemistry, biology, or a related field. 12+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs with a bachelor's degree, or 10+ years with a master's degree, or 7+ years with a PhD/PharmD/MD/DO/or international equivalent. Previous experience using safety databases, preferably Argus. Strong written and verbal communication skills. End-to-end case processing, including data entry, QC, medical review, and regulatory submissions. Project management skills and ability to organize and deliver large, complex projects independently. Working knowledge of drug development processes and activities. Strong analytical thinking to diagnose common situations, gather and review relevant information, and recommend solutions. Ability to work effectively across functions. Ability to be adaptable and work effectively in ambiguous situations. Working knowledge of MedDRA coding. Working knowledge of global regulations, guidelines, and industry best practices for end-to-end case management for devices, biologics, and drug products. Preferred Qualifications: Master’s degree in chemistry, biology, or a related field. Doctor of Philosophy (PhD) in chemistry, biology, or a related field. Doctor of Pharmacy (PharmD) or MD or DO or international equivalent. 5+ years of experience in vendor management and oversight. 3+ years of product development and/or postmarketing drug experience. 2+ years of previous functional lead/people management experience. The salary for this position ranges from $163,000 to $185,000 per year. In addition, this role is eligible for the Company’s short-term and long-term incentive programs. Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients. United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities.
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The job details are as follows:
Take the next step in your career now, scroll down to read the full role description and make your application. What We Do We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal, we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation. Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of "medicines for life". We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases. How you’ll contribute The Associate Global PV Case Management Director plays a key role in management and oversight of end-to-end case safety management activities spanning across our global commercial product portfolio. This position strategizes and implements plans to ensure compliance with global regulations and guidelines regarding safety data collection, management, and reporting for postmarketing ICSRs for efficiency, quality, and compliance impacts. This role is critical in ensuring that commercial operational aspects of pharmacovigilance activities are managed with rigorous global standards in proper documentation, evaluation processes, and decisions to support the overall global safety surveillance program and proper management of benefit/risk of UTC products. This position can be remote in the continental US, or in our RTP, NC office and will include about 15% international and domestic travel. Key Responsibilities: Process Evaluation and Strategy:
Evaluate, strategize, and execute process changes in response to regulatory updates, ensuring the effectiveness and efficiency of end-to-end commercial case processing; Initiate, plan, coordinate, and implement project plans to enhance process efficiencies and support business goals and objectives. Operational Oversight and Quality Assurance:
Oversee day-to-day quality and compliance for vendor staff supporting adverse effect processing for commercial UT products, including PM GSD workflows; Maintain unified PM Case Management operating procedures and monitor systems to ensure all PM adverse effects are processed and submitted per UT SOPs and industry standards. Regulatory Compliance and Guidance:
Provide strategic guidance to ensure compliance with global regulations and guidelines for safety data collection, management, and reporting of postmarketing ICSRs. Stakeholder and Vendor Management:
Act as the main point of contact and functional manager for day-to-day questions or issue escalation regarding PM case handling safety processes for internal stakeholders, vendors, and external partners. Training and Development:
Develop, facilitate, and provide training and training materials for AE, PC, and/or SRS collection and reporting of adverse effects in the commercial setting. Inspection and Audit Management:
Act as the point of contact for inspections and audits related to end-to-end case processing activities for PM case types. SOP and Procedural Document Management:
Initiate and lead the development and implementation of new or revised SOPs; Update and maintain procedural documents to reflect current practice related to GPS/PV Operations. Reconciliation and Compliance Oversight:
Oversee and resolve the PM reconciliation process, ensuring all discrepancies are addressed and compliance is maintained. Perform other duties as assigned. For this role you will need: Bachelor’s degree in nursing, chemistry, biology, or a related field. 12+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs with a bachelor's degree, or 10+ years with a master's degree, or 7+ years with a PhD/PharmD/MD/DO/or international equivalent. Previous experience using safety databases, preferably Argus. Strong written and verbal communication skills. End-to-end case processing, including data entry, QC, medical review, and regulatory submissions. Project management skills and ability to organize and deliver large, complex projects independently. Working knowledge of drug development processes and activities. Strong analytical thinking to diagnose common situations, gather and review relevant information, and recommend solutions. Ability to work effectively across functions. Ability to be adaptable and work effectively in ambiguous situations. Working knowledge of MedDRA coding. Working knowledge of global regulations, guidelines, and industry best practices for end-to-end case management for devices, biologics, and drug products. Preferred Qualifications: Master’s degree in chemistry, biology, or a related field. Doctor of Philosophy (PhD) in chemistry, biology, or a related field. Doctor of Pharmacy (PharmD) or MD or DO or international equivalent. 5+ years of experience in vendor management and oversight. 3+ years of product development and/or postmarketing drug experience. 2+ years of previous functional lead/people management experience. The salary for this position ranges from $163,000 to $185,000 per year. In addition, this role is eligible for the Company’s short-term and long-term incentive programs. Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients. United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities.
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