California, US residents click here (https://www.unither.com/docs/UNITHER%20Applicant%20Notice%20-%20%2812-22-23%29%20Final%202.15.24%20Combined%20EN%20and%20French.pdf#page=9) .

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. 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.

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.

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

Aid in successful execution of developmental, non-development programs (e.g., Phase 1-4 studies, PASS, etc.) and post-approval programs by ensuring robust safety data processing for UTC products for proper management of benefit risk and oversight of the case processing vendor(s). This role is accountable for the overall quality and proper execution of UT processes with respect to end-to-end case management activities of adverse events (AEs), product complaints (PCs) and/or special reporting situations (SRSs) for our development/non-development programs.

• Perform and document routine quality assurance checks of clinical trial and post-marketing cases

• Oversee and manage vendors to ensure fulfillment of end-to-end case processing requirements in accordance with UTC processes and global regulatory requirements

• Review trends in quality and/or processing issues, including proposing and implementing corrective and preventative actions relating to trends identified or areas of improvement identified

• Develop, facilitate and/or provide training and training materials for AE, PC, and/or SRS collection and reporting for developmental, non-development programs (e.g., Phase 1-4 studies, PASS, etc.) & post approval programs in accordance with SOPs, global regulations guidelines and conventions

• Remain current on global regulations, guidelines and industry best practices for end-to-end case management (SAEs) and ensure compliance with global regulations and guidelines regarding safety data collection, management, reporting and timely processing of individual case reports

• Escalate quality and or compliance issues to GPS management as appropriate

• Collaborate with team members on the development and implementation of new or revised SOPs; update and maintain procedural documents to reflect current practice related to GPS Operations

• Review and approve deviations/CAPAs for any ICSR related activity as necessary (related to quality failure)

• Perform all other duties as required

For this role you will need

Minimum Requirements

• Bachelor’s Degree in a related field (chemistry or biology) or BSN

• 5+ years of experience in pharmacovigilance in either case processing or quality assurance of ICSRs (clinical trial cases & post-marketing reports) with a Bachelor's Degree or

• 3+ years of experience in pharmacovigilance in either case processing or quality assurance of ICSRs (clinical trial cases & post-marketing reports) with a Master's degree

• Previous experience using Argus (preferred) or other safety databases

Preferred Qualifications

• Master’s Degree in a related field (chemistry or biology)

• 1+ years of experience in vendor management and oversight

• 1+ years of experience in clinical trial or product development

• Knowledge of data entry processing, from start to finish (QC, medical review, regulatory submissions)

• Prior clinical or post marketing experience

• Previous experience with vendor management

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.

While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients.

United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities

We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success.

We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work.