About Civica:

Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. “Race to the bottom” pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results.

Who suffers most? Patients.

Civica is a 501(c)(4) social welfare organization established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. An experienced team of health care and pharmaceutical industry leaders leads the organization.

Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and over 30 percent of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran’s Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile of essential medicines. Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients.”

Civica has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs.

More recently, Civica announced plans to develop, manufacture and deliver affordable biosimilar insulin, The consistent availability of affordable insulin will benefit people who ration their care or who have been forced to choose between this life-sustaining medicine and living expenses. Those who are uninsured or underinsured often pay the most out of pocket for their medications.

Long- and short-acting insulins will be produced and available in both vials and pre-filled pens – at no more than $30 per vial and no more than $55 for a pack of five pens.

Learn more about Civica’s plans and progress at  www.civicarx.org

Job Description:

The Quality Systems Specialist - Complaints, will join the Civica, Inc. (“Civica”) organization at the Petersburg, Virginia site by bringing their knowledge and experience in service to patients and pursuit of excellence in quality and compliance.  The Petersburg site serves as Civica’s new fill-finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications. The role is essential to ensure the Petersburg site’s product portfolio is continually monitored for pharmacovigilance expectations of applicable health authorities, ensuring patient safety through the continual feedback mechanism of pharmacovigilance into the development and reliable supply of quality medicines.

The position's responsibilities include ensuring the consistent application of Civica and regulatory expectations to the management of pharmacovigilance workstreams (i.e., complaints, adverse events, combination product complaints, and annual reporting). 

Essential Duties and Responsibilities:

• Responsible for handling market complaints and adverse events received for Civica Petersburg site’s product portfolio.
• Management of related quality system records, including documentation and review of related investigation reports, ensuring timely submission in accordance with applicable health authority timelines.
• Performing day-to-day activities of processing market complaints assigned as per the relevant SOPs.
• Support Civica pharmacovigilance program related to the Petersburg site’s products.
• Authors procedural documents related to area of responsibility.
• Interprets compliance and regulatory requirements for incorporation into the site’s pharmacovigilance program’s systems, procedures, and documentation.
• Track, trend, and analyze pharmacovigilance metrics for the site.
• Developing collaborative relationships with cross-functional support and providing guidance on standard pharmacovigilance processes.
• Support overall quality system programs as needed, including but not limited to training, supplier quality, change control, and deviation/CAPA systems.
• Support cGMP compliance and inspection readiness within the organization.
• Fosters the development of a Quality Culture within the cGMP environment.
• Practice and promote a safety and quality mindset and excellence approach to all activities. 

Basic Qualifications and Capabilities:

• Bachelor’s degree with 4+ years of pharmacovigilance/complaints or related quality system experience within a regulated industry.
• Strong organization, analytical, and execution skills with a proven track record of successfully managing multiple projects and priorities.
• Excellent interpersonal, verbal, and written communication skills. Experience using various software/electronic applications required.
• Self-motivated, flexible, and able to work in a small, fast-paced, dynamic environment.
• Ability to work autonomously and within established guidelines, procedures, and practices.
• Committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters.
• Continuously looking for opportunities to learn, build skills, and share knowledge with others. Experience in a process improvement environment.
• Proactively identify and work collaboratively to resolve problems, taking risk-based and compliant approaches to solutions.