United Therapeutics
Associate Director, Postmarketing PV Case Management
United Therapeutics, Montgomery, Alabama, United States, 36117
United Therapeutics Associate Director, Postmarketing PV Case Management Montgomery, Alabama Apply Now
The job details are as follows:
Make sure to apply quickly in order to maximise your chances of being considered for an interview Read the complete job description 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. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening 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 with regards to safety data collection, management, and reporting for postmarketing ICSRs for efficiency, quality, and compliance impacts. 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. Training and Development:
Develop and provide training materials for AE, PC, and/or SRS collection. Inspection and Audit Management:
Act as the point of contact for inspections and audits. SOP and Procedural Document Management:
Initiate and lead the development 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 experience. Project management skills. Working knowledge of drug development processes. Strong analytical thinking. Ability to work effectively across functions. Working knowledge of MedDRA coding. Working knowledge of global regulations and industry best practices. Preferred Qualifications Master’s degree or PhD in a related field. 5+ years of experience in vendor management. 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. 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:
Make sure to apply quickly in order to maximise your chances of being considered for an interview Read the complete job description 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. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening 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 with regards to safety data collection, management, and reporting for postmarketing ICSRs for efficiency, quality, and compliance impacts. 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. Training and Development:
Develop and provide training materials for AE, PC, and/or SRS collection. Inspection and Audit Management:
Act as the point of contact for inspections and audits. SOP and Procedural Document Management:
Initiate and lead the development 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 experience. Project management skills. Working knowledge of drug development processes. Strong analytical thinking. Ability to work effectively across functions. Working knowledge of MedDRA coding. Working knowledge of global regulations and industry best practices. Preferred Qualifications Master’s degree or PhD in a related field. 5+ years of experience in vendor management. 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. 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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