28 days old

Product Safety Consultant

CVS Caremark
Monroeville, PA 15146
**Job Description**

In the Senior Consultant role on the Specialty Product Safety Team, you will be responsible for managing the external reconciliation process of adverse drug event (ADE) and product complaint (PC) submission and performing the complete quality review of all adverse drug and product complaint forms. In addition, the Senior Consultant role will interact with individuals of varying levels within the company as well as specialty pharmaceutical manufacturers.

You will work both independently as well as collaboratively with other Product Safety team members to ensure accurate and timely manufacturer reporting and adherence to manufacturer contractual requirements.

Primary duties and responsibilities include:

o Complete daily reconciliation activities by reviewing notes from previous day entered in source system, identify possible adverse events and/or product complaints, and communicate to applicable teams to ensure timely submission.

o Analyze data and create weekly, monthly, and quarterly reports to be sent to manufacturers for their reconciliation processes and internal invoicing department based on contractual requirements.

o Communicate with manufacturers regarding inquiries of submitted forms, missing forms or other day to day ADE inquires

o Support manufacturer audits including gathering required data, SOPs, ADE training logs and other necessary materials

o Perform complete quality reviews of all adverse drug and product complaint forms

o Review for required data elements and content to adhere to manufacturer and/or FDA guidelines

o Communicate with pharmacy and nursing personnel for corrections or clarifications

This position requires strong collaboration skills as it is necessary to work cross functionally with Pharmacy Operations, the Compliance and Persistency Nurse Team, as well as Coram and ACS. The ideal candidate will have independent leadership skills, excellent communication skills, and deep specialty pharmacy system and workflow knowledge.

**Required Qualifications**

o A minimum 3+ years of Specialty Pharmacy Operations experience in a front-end/processing role

o Some travel (~10%) may be required

**Preferred Qualifications**

o Pharmaceutical manufacturer facing experience preferred

o Demonstrated ability to analyze issues or concerns quickly and provide resolution strategies to colleagues or clients

o Strong project management skills including attention to detail, follow-up and working to tight deadlines

o Proven ability to manage multiple concurrent projects and use effective judgment in prioritization and time allocation

o Ability to identify, interpret and analyze data trends, and draw logical conclusions

o Flexibility to adapt to changing requirements

o High level of independent judgment and initiative

o Proficient with MS Office including Word, PowerPoint, Excel

o Experience with Microsoft Access

o Excellent interpersonal, written and oral communication skills

o Proven ability to work across boundaries and collaborate with internal colleagues and external clients

o Knowledge and confidence to present to and interact with senior leadership and large audiences


High School Diploma or GED required

**Business Overview**

At CVS Health, we are joined in a common purpose: helping people on their path to better health. We are working to transform health care through innovations that make quality care more accessible, easier to use, less expensive and patient-focused. Working together and organizing around the individual, we are pioneering a new approach to total health that puts people at the heart.

We strive to promote and sustain a culture of diversity, inclusion and belonging every day. CVS Health is an equal opportunity and affirmative action employer. We do not discriminate in recruiting, hiring or promotion based on race, ethnicity, sex/gender, sexual orientation, gender identity or expression, age, disability or protected veteran status or on any other basis or characteristic prohibited by applicable federal, state, or local law. We proudly support and encourage people with military experience (active, veterans, reservists and National Guard) as well as military spouses to apply for CVS Health job opportunities.


Posted: 2020-12-21 Expires: 2021-01-21

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Product Safety Consultant

CVS Caremark
Monroeville, PA 15146

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