Position Summary: The Senior Consultant, Product Safety, will be responsible for supporting the Risk Evaluation and Minimization Strategies (REMS) SME to ensure organizational compliance to contractual and FDA requirements .
Primary duties and responsibilities include:
- Develop and maintain positive relationships with Pharmacy Operational teams that manage Risk Evaluation and Minimization Strategies (REMS)to promote open communication and engagement in support of REMS adherence
- Work collaboratively with operational team leaders and REMS-managing operational teams to ensure ongoing and timely training completions are in place for all REMS programs with training requirements; provide monthly status reports of training completion to PST REMS and Audit teams
- Support REMS SME for REMS training's, including coordination of webex meetings and meeting invites, loading of all required training's into Learnet/TheSource, and monitoring of training completions by operational staff to ensure compliance
- Support REMS SME for REMS Corrective Action Preventative Action (CAPA) responses from operational teams; ensure all CAPA responses are cataloged and stored appropriately for REMS and Audit SMEs
- Support and manage REMS Internal Audits to monitor program compliance and identify best practices or potential observations in collaboration with REMS SME
- Support REMS data reporting
- Support REMS external audits by assisting with required audit preparation based on audit agenda requirements; potentially support REMS and Audit SMEs by attending audits and providing non-clinical support functions
- Manage the Specialty REMS Master spreadsheet in collaboration with REMS SME; monitor updates to the FDA REMS programs and make required updates to master with REMS SME approval
The Senior Consultant will also support other key areas of the Product Safety team including adverse drug experience and product complaint reporting as well as supporting the PTEC programs when applicable:
- Support the Pharmaceutical Therapeutic Evaluation Committee (PTEC) chairperson to effectively project manage all non-clinical aspects of PTEC quarterly meetings; work proactively and collaboratively with all meeting stakeholders to ensure thorough and timely preparation/planning,execution, documentation, and follow-up to all committee stakeholders for quarterly meetings
- Adhoc support of the PST Adverse Drug Event reporting team as needed for business needs
This position requires strong collaboration skills as it is necessary to work cross functionally with various internal business units including but not limited to operations, account and clinical management teams, audit team and specialty drug file team. The ideal candidate will have independent leadership skills, excellent communication and organizational skills, and ability to complete all projects by targeted dates.
Required Qualifications: - Minimum of 2+ years of Specialty Pharmacy, PBM, Product Safety or related industry experience required
Preferred Qualifications:- Specialty pharmacy experience preferred
- Experience with monitoring of compliance programs
- Strong attention to detail skills - Excellent interpersonal, written and oral communication skills - Excellent organizational skills - Proven ability to work across boundaries and collaborate with internal colleagues and external clients - Demonstrated ability to analyze issues or concerns quickly and provide resolution strategies to colleagues or clients - Strong project management skills including attention to detail, follow-up and working to tight deadlines - Proven ability to manage multiple concurrent projects and use effective judgment in prioritization and time allocation - High level of independent judgment and initiative - Knowledge and confidence to interact with external partners such as pharmaceutical manufacturers, REMS hubs, auditors - Ability to identify, interpret and analyze data for internal auditing to assess operational compliance - Proficient with MS Office including Word, PowerPoint, Excel - Some travel (~10%) may be required
Education:High School Diploma/GED required
Bachelor's Degree or similar equivalent of work experience preferred
CVS Health, through our unmatched breadth of service offerings, is transforming the delivery of health care services in the U.S. We are an innovative, fast-growing company guided by values that focus on teamwork, integrity and respect for our colleagues and customers. What are we looking for in our colleagues? We seek fresh ideas, new perspectives, a diversity of experiences, and a dedication to service that will help us better meet the needs of the many people and businesses that rely on us each day. As the nation’s largest pharmacy health care provider, we offer a wide range of exciting and fulfilling career opportunities across our three business units – MinuteClinic, pharmacy benefit management (PBM) and retail pharmacy. Our energetic and service-oriented colleagues work hard every day to make a positive difference in the lives of our customers.
CVS Health is an equal opportunity employer. We do not discriminate in hiring or employment against any individual on the basis of race, ethnicity, ancestry, color, religion, sex/gender (including pregnancy), national origin, sexual orientation, gender identity or expression, physical or mental disability, medical condition, age, veteran status, military status, marital status, genetic information, citizenship status, unemployment status, political affiliation, or on any other basis or characteristic prohibited by applicable federal, state or local law. CVS Health will consider qualified job candidates with criminal histories in a manner consistent with federal, state and local laws. CVS Health will not discharge or in any other manner discriminate against any Colleague or applicant for employment because such Colleague or applicant has inquired about, discussed, or disclosed the compensation of the Colleague or applicant or another Colleague or applicant. Furthermore, we comply with the laws and regulations set forth in the following EEO is the Law Poster: EEO IS THE LAW
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For inquiries related to the application process or technical issues please contact the Kenexa Helpdesk at 1-855-338-5609. For technical issues with the Virtual Job Tryout assessment, contact the Shaker Help Desk at 1-877-987-5352. Please note that we only accept resumes via our corporate website: https://jobs.cvshealth.com/