Description |
Specific Responsibilities: This position has two main areas of responsibility:
(1) to oversee the execution of the Letairis Risk Evaluation and Mitigation Strategy (REMS)
(2) responsibility for evaluation and risk management work for Gilead products in the cardiovascular therapeutic area. The position will have several direct reports based in the UK and in the US.
Essential Duties and Job Functions: Letairis REMS
To oversee the execution of the Letairis Risk Evaluation and Mitigation Strategy (REMS; the LETAIRIS Education and Access Program [LEAP]), in collaboration with the Director of Commercial Operations. This includes the following tasks:
* To identify, retain, and manage external vendor relationships and contracts related to LEAP development, implementation, and evaluation.
To develop program processes and training for all stakeholders, including Gilead personnel and external vendors.
* To lead/attend regular meetings with the LEAP Coordinating Center, Specialty Pharmacies and/or other LEAP vendors to review project specific issues, obtain updates and verify adherence to LEAP requirements/processes
* To coordinate the development and legal/regulatory approval of LEAP patient and healthcare professional materials, in conjunction with Marketing.
* To oversee the completion of annual audits of the LEAP Coordinating Center, Specialty Pharmacies and other LEAP vendors
* To work with Gilead National Account Managers and Sales Field Force, as appropriate, to ensure issues preventing patient access to drug are resolved quickly
* To manage program operating budgets and oversees expense management processes related to LEAP implementation.
Other tasks related to LEAP include the following:
* To compile and/or provide critical review of reports provided to FDA summarizing data obtained from the LEAP
* To ensure monitoring systems are in place and are managed effectively in order to evaluate the effectiveness of LEAP. In particular, to oversee the design and execution of Knowledge, Attitude and Behavior surveys and Pregnancy Root Cause Analysis work
* To establish effective working relationships with key opinion leaders locally and nationally to ensure continuous quality improvement of LEAP
* To provide advice and oversight on programs related to LEAP, including the LabSync program
Other Evaluation and Risk Management Responsibilities (cardiovascular products)
* Responsible for the following activities:
- Signal detection and workups
- Authorship of Company Core Data Sheet sections and associated supporting documentation
- Authorship of aggregate safety reports including PSURs and ASRs
- Authorship of risk management plans
- Authorship of responses to regulatory agency safety enquiries
- Contribution to safety analyses in Regulatory submissions (e.g. MAAs, NDAs)
* Collaboration with partner companies on safety evaluation for co-licensed products
* Line management responsibility; mentoring and coaching others at more junior levels
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Requirements |
Knowledge, Experience and Skills:
* Highly experienced in all aspects of drug safety evaluation work
* Must be able to become an expert on the functions and inner workings of the LEAP and specialty pharmaceutical distribution networks
* Able to analyze highly complex problems and situations, to provide logical and clear recommendations and to lead any required actions
* Excellent understanding of good pharmacovigilance practices and current drug safety regulations
* Demonstrated ability to identify safety signals through assessment of case reports as well as other data
* Excellent verbal and written communication skills; able to present complex information clearly
* Demonstrated ability to collaborate effectively cross-functionally
* Able to make significant contributions to safety committee or other meeting discussions (internal or with partner companies)
* Demonstrated ability to initiate effective process improvements
* Academic level: Bachelor of Science Degree in life sciences subject, pharmacy or nursing, ideally with MSc or PhD, or MD
When applying, please specify "LatPro.com - position title" at the top of your resume.
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