Drug Safety Director - Specialty Pharmacy

  • Company: CVS Health
  • Location: Northbrook, Illinois
  • Posted: March 02, 2018
  • Reference ID: 721953BR
Job Description
The Director of Specialty Pharmacovigilance is responsible for leading all product safety aspects of our specialty drug manufacturer relationships including adverse event reporting and REMS program administration. This position is critical for effectively ensuring that we conduct our specialty pharmacy business with the highest safety standards, integrity, and consistency/compliance with relevant federal agencies, including the FDA.

Primary duties and responsibilities include:

· Responsible for providing strategic leadership and oversight of the pharmacovigilance program which encompasses advising the organization on the US regulatory landscape (e.g., requirements, precedence, guidance, trends) and detailed safety-related requirements for signal detection, and REMS by understanding and applying FDA and global regulations.
· Oversee development and ongoing refinement of specific contractual language for obligations related to adverse events, REMS, and product safety requirements.
· Support product safety audits or inspections conducted by drug manufacturers and regulatory/compliance entities, including serving as the liaison with the audit team to follow up on specific audit findings, documentation, and translation to CAPA.
· Manage highly complex relationships, understand the multifaceted nature of pharmaceutical manufacturers and oversee and/or participate in drug safety activities, including adverse event reporting and REMS compliance.
· Work collaboratively with Professional Practice, Manufacturer Services, Trade, Specialty Pharmacy Operations, Medical Affairs and Legal to assure product safety as well as compliance to contractual obligations across all pharmacies.
· This position may also lend support and leadership to the specialty definition, pipeline, and pharmacy technology and evaluation committee processes as well as other internal department processes
· Maintain overall direction, coordination and evaluation of the Specialty Product Safety department through planning, assigning, and directing work, appraising performance, rewarding and disciplining employees, addressing complaints and resolving problems
· Train, mentor and provide leadership to Product Safety team members to:
- Monitor, review and lead the implementation and maintenance of product safety / risk and pharmacovigilance reporting.
- Provide oversight to the mandated training requirements as set forth by our pharmaceutical manufacturer contractual requirements.
- In collaboration with legal, trade, and contract operations, participate in contract discussions with internal and external business partners; lead the contract response as it relates to product safety / risk and ADE reporting.
- Create, maintain and implement standard operating procedures to support all aspects of product safety / risk and pharmacovigilance reporting.
- Evaluate and identify opportunities to improve the customer experience and create higher levels of service that are repeatable and sustainable.
· Drive strategic plans to improve performance, reliability and results through identifying trends and assessing the underlying root cause of service issues.
- Standardize procedures and workflow to improve efficiency, quality, service and performance.

Strong leadership skills with a high level of initiative and team accountability are required to manage and motivate a high performing team of clinicians and non-clinicians. You will serve as the expert on key business initiatives and provide insight into strategic planning. Excellent interpersonal skills, a strategic vision, critical thinking and creativity will aid in your success to have best in class standards with regard to pharmacovigilance programs. Working effectively in a matrixed environment where the ability to influence across departments is key to success.

This position can be located in Northbrook, IL or Monroeville, PA.



Required Qualifications
- 10+ years of Specialty Pharmacy, PBM, Operations or related industry experience required
- 3 years drug / product safety experience
- 5+ years of leadership experience required
- A minimum of one (1) year experience in interfacing directly with external clients is required.
- Demonstrated high level of client service skills through execution with accuracy, responsiveness, reliability and
professionalism on every interaction, often times with tight timelines.
- A professional presence, solid presentation and communication skills are a requirement in engaging and interacting with pharmaceutical manufacturers and internal partners
- Strong strategic, creative and solution-oriented thinking capability using sound business judgment and decision making
- Demonstrated leadership skills, prioritization, and strong project management skills Knowledge and confidence to present to and interact with senior leadership and large audiences of clinical professionals,
executives, clients and customers.
- Proficient with MS Office including Word, PowerPoint, Excel, Project, Visio, and Sharepoint. Flexible hours and ~15% travel are required


Preferred Qualifications
Specialty pharmacy or healthcare industry experience preferred Pharmaceutical manufacturer facing experience
preferred ·
Knowledge and experience in regulatory compliance and audit
U.S. and/or global Pharmacovigilance experience preferred


Education
Bachelors degree in Pharmacy or PharmD ·
MBA, JD or other advanced degree preferred.


Business Overview
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 and EEO IS THE LAW SUPPLEMENT

Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. If you require assistance to apply for this job, please contact us by clicking EEO AA CVS Health

CVS Health does not require nor expect that applicants disclose their compensation history during the application, interview, and hiring process.

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/

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