Pharmacovigilance and Regulatory Specialist

Pharmacovigilance and Regulatory Specialist

Location: Denver United States

Job Description:

University of Colorado Anschutz Medical Campus

Department: Clinical Research Operations Support – Office of the Vice Chancellor for Research

Job Title:  Pharmacovigilance and Regulatory Specialist

Position #: 00849958 – Requisition #: 40313

Job Summary:

Meet with PI and study team to review the progress of the application and development of the subsequent trial, assist in the development of applicable protocol materials before submission to the FDA, review any adverse safety events, protocol deviations and exclusions, enrollment and follow-up of participants, missing data and data quality controls, and any new medical advances that may require changes in the study protocol to ensure adherence to the protocol and IND/IDE application. Work closely with the Medical Director and Principal Investigator in the development of the safety monitoring and related sections of the CTD. Direct communications and meetings about the clinical trial including regulatory compliance, scientific review committees, the manufacturing sites, the hospital-based research administration, and other entities on campus. Maintain document version control as updates and edits are made during the IND/IDE application process and throughout the protocol life cycle. Work with the Project Manager to elevate any significant barriers delaying the IND/IDE application and operationalizing of the protocol to the PI and OVCR leadership. Monitor e-mail for safety reports and facilitate a timely review by the Medical Director, coordinate with the FDA as applicable and ensure that safety reports with appropriate documentation are submitted to the applicable regulatory agencies in a timely fashion. Provide safety reports and other regulatory documents as needed to the Study Monitoring Committee prior to each meeting. Coordinate with the appropriate Study Monitoring Committee to ensure that all applicable safety reports are reviewed in accordance with their charter. Coordinate with the regulatory team to ensure that consistent information is submitted to all relevant review processes with oversight of safety data. Ensure that TMFs are compliant with all applicable federal guidance. Provide regulatory support for FDA submissions and interactions, as needed. Position is fully remote reporting to the University of Colorado Anschutz Medical Campus in Aurora, CO. Employee must appear in person at worksite at least once a month.

Work Location:

Remote – Position is fully remote reporting to the University of Colorado Anschutz Medical Campus in Aurora, CO. Employee must appear in person at worksite at least once a month.

Why Join Us:

CU Anschutz seeks a qualified candidate to join the newly developed IND/IDE Support Office. The mission of the office is to facilitate efficient start up processes for investigator-initiated research under FDA oversight, ensure that this research is feasible and appropriately resourced, alleviate administrative burdens on investigators, and mitigate compliance risks for the institution. This will be accomplished by providing robust and tailored centralized support for investigator-initiated IND and IDE submissions. The Pharmacovigilance Specialist will assess the safety of the research participants throughout the course of the trials for which the IND/IDE Support Office provides services and oversight. The Pharmacovigilance Specialist must have experience with clinical trials so that they can monitor the progress of the trial for adequate enrollment, appropriate follow-up, adherence to protocol, and good data collection.  This position would work directly with the Medical Monitor, Principal Investigators (PIs) and closely coordinate with institutional partners including the Clinical Research Administrative Office, the IRB, clinical teams and manufacturing facilities as applicable. 

Why work for the University?

We have AMAZING benefits and offer exceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including:

• Medical: Multiple plan options

• Dental: Multiple plan options

• Additional Insurance: Disability, Life, Vision

• Retirement 401(a) Plan: Employer contributes 10% of your gross pay

• Paid Time Off: Accruals over the year

• Vacation Days: 22/year (maximum accrual 352 hours)

• Sick Days: 15/year (unlimited maximum accrual)

• Holiday Days: 10/year

• Tuition Benefit: Employees have access to this benefit on all CU campuses

• ECO Pass: Reduced rate RTD Bus and light rail service

• There are many additional perks & programs with the CU Advantage.

Qualifications:

Job Requirements:

• Requires a Bachelor’s degree in Regulatory Affairs, Pharmacy, Healthcare, Sciences, or a directly related field and three (3) years of clinical research experience.

• Must have experience in each of the following skills: Pharmacovigilance; Regulatory Affairs; Clinical trial regulatory work; Risk assessment and mitigation; Adverse event (AE) analysis; Databases: Trial Master File database, Oncore or other CTMS, Electronic Data Capture systems; Safety parameters, protocols, and reporting.

Applicants must meet minimum qualifications at the time of hire.

Anticipated Pay Range:

The starting salary range for this position has been established as $68,994.00 - $115,911.00 per year.

The above salary range represents the University’s good faith and reasonable estimate of the range of possible compensation at the time of posting.

This position is not eligible for overtime compensation.

Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.

Equal Employment Opportunity Statement:

CU is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing nondiscrimination in employment. We are committed to creating a workplace where all individuals are treated with respect and dignity, and we encourage individuals from all backgrounds to apply, including protected veterans and individuals with disabilities.

Background Check Statement:

The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.

Vaccination Statement:

CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases. If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program. 

Job Category

: Research Services 

Primary Location

: Remote 

Department: U0001 -- Anschutz Med Campus or Denver - 21976 - ADM AVC Clinical Res Operation 

Schedule

: Full-time