United Therapeutics
Associate Director, Postmarketing PV Case Management
United Therapeutics, Montpelier, Vermont, us, 05604
United Therapeutics Associate Director, Postmarketing PV Case Management Montpelier, Vermont
The job details are as follows:
Before applying for this role, please read the following information about this opportunity found below. 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. Our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. We have successfully gained FDA approval for five medicines and are always conducting new clinical trials. 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. Process Evaluation and Strategy:
Evaluate, strategize, and execute process changes in response to regulatory updates. Operational Oversight and Quality Assurance:
Oversee day-to-day quality and compliance for vendor staff supporting adverse effect processing. Regulatory Compliance and Guidance:
Provide strategic guidance to ensure compliance with global regulations. Stakeholder and Vendor Management:
Act as the main point of contact for day-to-day questions or issue escalation regarding PM case handling safety processes. Training and Development:
Develop, facilitate, and provide training for AE, PC, and/or SRS collection and reporting of adverse effects. Inspection and Audit Management:
Act as the point of contact for inspections and audits related to end-to-end case processing activities. SOP and Procedural Document Management:
Initiate and lead the development and implementation of new or revised SOPs. Reconciliation and Compliance Oversight:
Oversee and resolve the PM reconciliation process. 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. 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. Strong analytical thinking to diagnose common situations 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 and industry best practices for end-to-end case management. 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. 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:
Before applying for this role, please read the following information about this opportunity found below. 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. Our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. We have successfully gained FDA approval for five medicines and are always conducting new clinical trials. 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. Process Evaluation and Strategy:
Evaluate, strategize, and execute process changes in response to regulatory updates. Operational Oversight and Quality Assurance:
Oversee day-to-day quality and compliance for vendor staff supporting adverse effect processing. Regulatory Compliance and Guidance:
Provide strategic guidance to ensure compliance with global regulations. Stakeholder and Vendor Management:
Act as the main point of contact for day-to-day questions or issue escalation regarding PM case handling safety processes. Training and Development:
Develop, facilitate, and provide training for AE, PC, and/or SRS collection and reporting of adverse effects. Inspection and Audit Management:
Act as the point of contact for inspections and audits related to end-to-end case processing activities. SOP and Procedural Document Management:
Initiate and lead the development and implementation of new or revised SOPs. Reconciliation and Compliance Oversight:
Oversee and resolve the PM reconciliation process. 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. 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. Strong analytical thinking to diagnose common situations 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 and industry best practices for end-to-end case management. 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. 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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