United Therapeutics Associate Director, Postmarketing PV Case Management Salem, Oregon The job details are as follows:
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.
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. This role is critical in ensuring that commercial operational aspects of pharmacovigilance activities are managed with rigorous global standards.
Responsibilities include:
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 regarding PM case handling safety processes.
Training and Development:
Develop, facilitate, and provide training and training materials for AE, PC, and/or SRS collection.
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.
Project management skills and ability to organize and deliver large, complex projects independently.
Working knowledge of drug development processes and activities.
Strong analytical thinking.
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 guidelines.
Preferred Qualifications:
Master's degree or 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. 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.
•
Receive real-time job alerts and never miss the right job again
Yakima Valley Farm Workers Clinic
US - OR - OR - Hubbard
December 23, 2024
Caseload split roughly 50/50 between Salud Medical Center in Woodburn, Oregon and Lancaster Family Health in Salem, Oregon. Mileage between work sites reimbursed. • In this role, you'll provide mental health services as determined in the treatment or care plan of the client. Support patients and...
Yakima Valley Farm Workers Clinic
US - OR - OR - Mount Angel
December 23, 2024
Caseload split roughly 50/50 between Salud Medical Center in Woodburn, Oregon and Lancaster Family Health in Salem, Oregon. Mileage between work sites reimbursed. • In this role, you'll provide mental health services as determined in the treatment or care plan of the client. Support patients and...
Yakima Valley Farm Workers Clinic
US - OR - OR - Canby
December 23, 2024
Caseload split roughly 50/50 between Salud Medical Center in Woodburn, Oregon and Lancaster Family Health in Salem, Oregon. Mileage between work sites reimbursed. • In this role, you'll provide mental health services as determined in the treatment or care plan of the client. Support patients and...
Yakima Valley Farm Workers Clinic
US - OR - OR - Saint Paul
December 23, 2024
Caseload split roughly 50/50 between Salud Medical Center in Woodburn, Oregon and Lancaster Family Health in Salem, Oregon. Mileage between work sites reimbursed. • In this role, you'll provide mental health services as determined in the treatment or care plan of the client. Support patients and...
US - OR - OR - Wilsonville
January 1, 2025
ecoShuttle Is Hiring Local CDL B Shuttle, Bus,Charter, & Route Drivers In The Hillsboro, OR Area Salary Range: $22.50-$55+ Per Hour (Dependent Upon Run Types and Hours) Must Have Valid Class A or B CDL With Passenger & Air Brake Endorsements Must Have At Least 2 Years of Verifiable Driving...
Yakima Valley Farm Workers Clinic
US - OR - OR - Molalla
December 23, 2024
Caseload split roughly 50/50 between Salud Medical Center in Woodburn, Oregon and Lancaster Family Health in Salem, Oregon. Mileage between work sites reimbursed. • In this role, you'll provide mental health services as determined in the treatment or care plan of the client. Support patients and...
Yakima Valley Farm Workers Clinic
US - OR - OR - Woodburn
December 23, 2024
Caseload split roughly 50/50 between Salud Medical Center in Woodburn, Oregon and Lancaster Family Health in Salem, Oregon. Mileage between work sites reimbursed. • In this role, you'll provide mental health services as determined in the treatment or care plan of the client. Support patients and...
Yakima Valley Farm Workers Clinic
US - OR - OR - Mulino
December 23, 2024
Caseload split roughly 50/50 between Salud Medical Center in Woodburn, Oregon and Lancaster Family Health in Salem, Oregon. Mileage between work sites reimbursed. • In this role, you'll provide mental health services as determined in the treatment or care plan of the client. Support patients and...
Yakima Valley Farm Workers Clinic
US - OR - OR - Lake Oswego
December 23, 2024
Caseload split roughly 50/50 between Salud Medical Center in Woodburn, Oregon and Lancaster Family Health in Salem, Oregon. Mileage between work sites reimbursed. • In this role, you'll provide mental health services as determined in the treatment or care plan of the client. Support patients and...
Yakima Valley Farm Workers Clinic
US - OR - OR - Salem
December 23, 2024
Caseload split roughly 50/50 between Salud Medical Center in Woodburn, Oregon and Lancaster Family Health in Salem, Oregon. Mileage between work sites reimbursed. • In this role, you'll provide mental health services as determined in the treatment or care plan of the client. Support patients and...
Yakima Valley Farm Workers Clinic
US - OR - OR - Dundee
December 23, 2024
Caseload split roughly 50/50 between Salud Medical Center in Woodburn, Oregon and Lancaster Family Health in Salem, Oregon. Mileage between work sites reimbursed. • In this role, you'll provide mental health services as determined in the treatment or care plan of the client. Support patients and...
Yakima Valley Farm Workers Clinic
US - OR - OR - Scotts Mills
December 23, 2024
Caseload split roughly 50/50 between Salud Medical Center in Woodburn, Oregon and Lancaster Family Health in Salem, Oregon. Mileage between work sites reimbursed. • In this role, you'll provide mental health services as determined in the treatment or care plan of the client. Support patients and...
Yakima Valley Farm Workers Clinic
US - OR - OR - Sherwood
December 23, 2024
Caseload split roughly 50/50 between Salud Medical Center in Woodburn, Oregon and Lancaster Family Health in Salem, Oregon. Mileage between work sites reimbursed. • In this role, you'll provide mental health services as determined in the treatment or care plan of the client. Support patients and...
Yakima Valley Farm Workers Clinic
US - OR - OR - Gervais
December 23, 2024
Caseload split roughly 50/50 between Salud Medical Center in Woodburn, Oregon and Lancaster Family Health in Salem, Oregon. Mileage between work sites reimbursed. • In this role, you'll provide mental health services as determined in the treatment or care plan of the client. Support patients and...
Yakima Valley Farm Workers Clinic
US - OR - OR - Wilsonville
December 23, 2024
Caseload split roughly 50/50 between Salud Medical Center in Woodburn, Oregon and Lancaster Family Health in Salem, Oregon. Mileage between work sites reimbursed. • In this role, you'll provide mental health services as determined in the treatment or care plan of the client. Support patients and...
Yakima Valley Farm Workers Clinic
US - OR - OR - Newberg
December 23, 2024
Caseload split roughly 50/50 between Salud Medical Center in Woodburn, Oregon and Lancaster Family Health in Salem, Oregon. Mileage between work sites reimbursed. • In this role, you'll provide mental health services as determined in the treatment or care plan of the client. Support patients and...
US - OR - OR - Eugene
January 10, 2025
$7500 Sign-on Bonous for External Candidates! For those who want to invent the future of health care, here's your opportunity. We're going beyond basic care to health programs integrated across the entire continuum of care. Join us to start Caring. Connecting. Growing together. Primary...
US - OR - OR - Salem
December 13, 2024
Corvallis Transit Is Hiring CDL Shuttle Drivers In Corvallis, OR *Make $23 Per Hour- 100% Paid Health Benefits* Valid CDL B License w/ Passenger Endorsement REQUIRED Our mission is to provide the best-in-class transportation solutions to our valued passengers at Corvallis Transit, while maintaining...
Yakima Valley Farm Workers Clinic
US - OR - OR - West Linn
December 23, 2024
Caseload split roughly 50/50 between Salud Medical Center in Woodburn, Oregon and Lancaster Family Health in Salem, Oregon. Mileage between work sites reimbursed. • In this role, you'll provide mental health services as determined in the treatment or care plan of the client. Support patients and...
Yakima Valley Farm Workers Clinic
US - OR - OR - Aurora
December 23, 2024
Caseload split roughly 50/50 between Salud Medical Center in Woodburn, Oregon and Lancaster Family Health in Salem, Oregon. Mileage between work sites reimbursed. • In this role, you'll provide mental health services as determined in the treatment or care plan of the client. Support patients and...
Yakima Valley Farm Workers Clinic
US - OR - OR - Lafayette
December 23, 2024
Caseload split roughly 50/50 between Salud Medical Center in Woodburn, Oregon and Lancaster Family Health in Salem, Oregon. Mileage between work sites reimbursed. • In this role, you'll provide mental health services as determined in the treatment or care plan of the client. Support patients and...
Yakima Valley Farm Workers Clinic
US - OR - OR - Saint Benedict
December 23, 2024
Caseload split roughly 50/50 between Salud Medical Center in Woodburn, Oregon and Lancaster Family Health in Salem, Oregon. Mileage between work sites reimbursed. • In this role, you'll provide mental health services as determined in the treatment or care plan of the client. Support patients and...
Yakima Valley Farm Workers Clinic
US - OR - OR - Silverton
December 23, 2024
Caseload split roughly 50/50 between Salud Medical Center in Woodburn, Oregon and Lancaster Family Health in Salem, Oregon. Mileage between work sites reimbursed. • In this role, you'll provide mental health services as determined in the treatment or care plan of the client. Support patients and...
Yakima Valley Farm Workers Clinic
US - OR - OR - Tualatin
December 23, 2024
Caseload split roughly 50/50 between Salud Medical Center in Woodburn, Oregon and Lancaster Family Health in Salem, Oregon. Mileage between work sites reimbursed. • In this role, you'll provide mental health services as determined in the treatment or care plan of the client. Support patients and...
Yakima Valley Farm Workers Clinic
US - OR - OR - Keizer
December 23, 2024
Caseload split roughly 50/50 between Salud Medical Center in Woodburn, Oregon and Lancaster Family Health in Salem, Oregon. Mileage between work sites reimbursed. • In this role, you'll provide mental health services as determined in the treatment or care plan of the client. Support patients and...
Yakima Valley Farm Workers Clinic
US - OR - OR - Donald
December 23, 2024
Caseload split roughly 50/50 between Salud Medical Center in Woodburn, Oregon and Lancaster Family Health in Salem, Oregon. Mileage between work sites reimbursed. • In this role, you'll provide mental health services as determined in the treatment or care plan of the client. Support patients and...
Yakima Valley Farm Workers Clinic
US - OR - OR - Aumsville
December 23, 2024
Caseload split roughly 50/50 between Salud Medical Center in Woodburn, Oregon and Lancaster Family Health in Salem, Oregon. Mileage between work sites reimbursed. • In this role, you'll provide mental health services as determined in the treatment or care plan of the client. Support patients and...