Specialist Pharm Audit Programs (Remote)
Address: Remote
Job ID 1653246BR
Job Summary:
Responsible for the timely review and submission of pharmacovigilance cases for the specialty divisions. This position will monitor the clinical adverse event worklist in real time to ensure cases are reviewed for reportability and submitted to a pharma client or the FDA accurately and timely per our SOP and contractual obligations. This role is also responsible for the review and auditing of all submitted pharmacovigilance cases within 1 business day, working the Quality Audit worklist in real time. Additionally, this role is responsible for tasks that support keeping the organization compliant with contractual obligations to pharma partners including safety event report reconciliations, team inbox management, daily report review, HIPAA compliance, pharma trainings, REMS compliance, and pharma audit preparation support.
Job Responsibilities:
Founded in 1901, Walgreens (www.walgreens.com) has a storied heritage of caring for communities for generations and proudly serves nearly 9 million customers and patients each day across its approximately 8,500 stores throughout the U.S. and Puerto Rico, and leading omni channel platforms. Walgreens has approximately 220,000 team members, including nearly 90,000 healthcare service providers, and is committed to being the first choice for retail pharmacy and health services, building trusted relationships that create healthier futures for customers, patients, team members and communities.
Walgreens is the flagship U.S. brand of Walgreens Boots Alliance, Inc. (Nasdaq: WBA), an integrated healthcare, pharmacy and retail leader. Its retail locations are a critical point of access and convenience in thousands of communities, with Walgreens pharmacists playing a greater role as part of the healthcare system and patients care teams than ever before. Walgreens Specialty Pharmacy provides critical care and pharmacy services to millions of patients with rare disease states and complex, chronic conditions.
The actual salary an employee can expect to receive, plus bonus pursuant to the terms of any bonus plan if applicable, will depend on experience, seniority, geographic location, and other factors permitted by law. To review benefits, please visit jobs.walgreens.com/benefits More Company information is available at www.walgreensbootsalliance.com.
Basic Qualifications
Preferred Qualifications
Salary Range: $18.25 - $24.35 / Hourly
Responsible for the timely review and submission of pharmacovigilance cases for the specialty divisions. This position will monitor the clinical adverse event worklist in real time to ensure cases are reviewed for reportability and submitted to a pharma client or the FDA accurately and timely per our SOP and contractual obligations. This role is also responsible for the review and auditing of all submitted pharmacovigilance cases within 1 business day, working the Quality Audit worklist in real time. Additionally, this role is responsible for tasks that support keeping the organization compliant with contractual obligations to pharma partners including safety event report reconciliations, team inbox management, daily report review, HIPAA compliance, pharma trainings, REMS compliance, and pharma audit preparation support.
Job Responsibilities:
- Responsible for daily, weekly, monthly and quarterly Adverse Event review and reconciliation utilizing each pharma partners unique template and guidelines for completion.
- Supports Pharma Training specialist by assigning, distributing, and maintaining all pharma training records for specialty divisions to keep us contractually compliant with pharma partners. Training includes pharma program SOP, QRG, WIG adverse event training, clinical training and corrective and preventive action required training.
- Manages Pharma Audit Team inbox addressing and responding to daily inquiries from pharma partners, operations team members and various internal and external partners.
- Drafts and submits corrective and preventive action plans to ensure that we are remedying areas that have been identified as opportunities for improvement and escalate trends and/or outstanding issues to supervisors and manager.
- Track and outreach for various manufacturer confirmation receipts within specified number of business days as outlined in contracts with pharma partners.
- Responsible for real time monitoring and completion of referrals in the Clinical Adverse Event worklist within 1 business day of event being reported to our pharmacy. Review of each referral for reportability based on contractual guidelines and if reportable ensuring all safety cases are documented accurately and submitted to the pharma partner as contractually required.
- Research surveys, referrals and patient notes to ensure details of safety events are reported accurately and completely.
- Responsible for cross-functional audit team support related to daily audits of operating system outputs specific to drug safety.
- Responsible for real time monitoring and completion of referrals in the Clinical Quality Audit worklist within 1 business day of event being reported to our pharmacy. Review all submitted safety events within each referral and amend and resubmit report if deemed necessary.
- Responsible for real time monitoring and completion of referrals in the Digital AE survey worklist, which includes patient self-service order surveys that are escalated due to safety events that were reported.
- Identify active patients with expired manufacturer HIPAA authorizations and send out Universal HIPAA authorization for signature. This includes tracking and follow-up with patient if not received via phone calls on specific days as outlined by internal policy.
- Support manufacturer required periodic quality checks that include reviewing patient surveys, notes, dispense history, and call monitoring as outlined in pharma contracts.
- Conducts pre-audit/desk top audits to ensure all contractual requirements, including but not limited to, adverse event reporting, REMS requirements and Pharma Program SOPs are being followed.
- Other responsibilities as judgment or necessity dictate.
Founded in 1901, Walgreens (www.walgreens.com) has a storied heritage of caring for communities for generations and proudly serves nearly 9 million customers and patients each day across its approximately 8,500 stores throughout the U.S. and Puerto Rico, and leading omni channel platforms. Walgreens has approximately 220,000 team members, including nearly 90,000 healthcare service providers, and is committed to being the first choice for retail pharmacy and health services, building trusted relationships that create healthier futures for customers, patients, team members and communities.
Walgreens is the flagship U.S. brand of Walgreens Boots Alliance, Inc. (Nasdaq: WBA), an integrated healthcare, pharmacy and retail leader. Its retail locations are a critical point of access and convenience in thousands of communities, with Walgreens pharmacists playing a greater role as part of the healthcare system and patients care teams than ever before. Walgreens Specialty Pharmacy provides critical care and pharmacy services to millions of patients with rare disease states and complex, chronic conditions.
The actual salary an employee can expect to receive, plus bonus pursuant to the terms of any bonus plan if applicable, will depend on experience, seniority, geographic location, and other factors permitted by law. To review benefits, please visit jobs.walgreens.com/benefits More Company information is available at www.walgreensbootsalliance.com.
Basic Qualifications
- High School Diploma or equivalent GED; or equivalent combination of education and/or work experience
- 2 years' work experience with healthcare or pharmacy setting.
- Intermediate level skills in Microsoft Office suite of programs (Word, Excel, PowerPoint)
- Excellent administrative and organizational skills
- Excellent written and oral communication skills
- Willing to travel up to10% of the time for business purposes (within state and out of state).
Preferred Qualifications
- Associates Bachelor's degree in healthcare, business, or related area of study; or equivalent combination of education and/or related work experience.
- Experience contractual obligations to pharma partners around pharma trainings and/or pharmacovigilance.
- Experience creating statistical reports.
- Detail-oriented and with analytical skills.
- Ability to think and act independently.
- Self-motivated and ability to meet deadlines.
An employee in this position can expect an hourly rate between $18..25 to $21.30 The actual salary will depend on experience, seniority, geographic location, and other factors permitted by law. This job posting will remain open for 5 days from the job posting date. To review benefits, please click here jobs.walgreens.com/benefits. If you are applying on a job board or unable to click on the link, please copy and paste this URL into your browser jobs.walgreens.com/benefits.
Salary Range: $18.25 - $24.35 / Hourly