United Therapeutics
Associate Director, Postmarketing PV Case Management
United Therapeutics, Boise, Idaho, United States, 83708
United Therapeutics Associate Director, Postmarketing PV Case Management Boise, Idaho
The job details are as follows:
Candidates should take the time to read all the elements of this job advert carefully Please make your application promptly. 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; Initiate, plan, coordinate, and implement project plans to enhance process efficiencies. Operational Oversight and Quality Assurance:
Oversee day-to-day quality and compliance for vendor staff supporting adverse effect processing for commercial UT products; Maintain unified PM Case Management operating procedures. 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. Training and Development:
Develop, facilitate, and provide training materials 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, ensuring all discrepancies are addressed. 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. Project management skills and ability to organize and deliver large, complex projects independently. Working knowledge of drug development processes. Strong analytical thinking and problem-solving skills. Ability to work effectively across functions. Working knowledge of MedDRA coding and global regulations. Preferred Qualifications Master’s degree or Doctor of Philosophy (PhD) in a related field. 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. 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! You will learn, grow, contribute, and have fun 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:
Candidates should take the time to read all the elements of this job advert carefully Please make your application promptly. 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; Initiate, plan, coordinate, and implement project plans to enhance process efficiencies. Operational Oversight and Quality Assurance:
Oversee day-to-day quality and compliance for vendor staff supporting adverse effect processing for commercial UT products; Maintain unified PM Case Management operating procedures. 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. Training and Development:
Develop, facilitate, and provide training materials 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, ensuring all discrepancies are addressed. 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. Project management skills and ability to organize and deliver large, complex projects independently. Working knowledge of drug development processes. Strong analytical thinking and problem-solving skills. Ability to work effectively across functions. Working knowledge of MedDRA coding and global regulations. Preferred Qualifications Master’s degree or Doctor of Philosophy (PhD) in a related field. 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. 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! You will learn, grow, contribute, and have fun 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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