Reporting to the Executive Director, US Medical Center of Excellence, the Sr. Manager/Head of Medical Information and Local Drug Safety Responsible will lead the Medical Information function and optimize the various processes and procedures to support Medical Information including process and procedure management, Call Center vendor oversight, partner relationship management, content development (Standard Response Letter development, review and maintenance), query escalation management, insights analysis, literature review, conference support and reporting. In addition, this role will perform the duties of the LDSR to ensure the US organization and its designees have completed the required pharmacovigilance training (including the maintenance of these records) and is prepared for audit. This individual will also conduct the medical review for all Medical Affairs materials undergoing Medical Legal and Compliance review and will assist with scientific writing and content development on various ad hoc projects.
Direct Medical Information Services for the US Affiliate
- Develop and maintain medical content for US Standard Response Letters in coordination with the Global Medical Information team.
- Proactively identify emerging data (company sponsored or external via literature reviews) to update existing US Standard Response Letters, with ongoing collaboration with Global Medical Information.
- Proactively interface with cross-functional team members to identify needs for FAQs or where novel US Standard Response Letters require development.
- Direct the Call Center vendor to ensure timely and accurate fulfilment of medical information requests from healthcare professionals, consumers, and internal colleagues.
- Conduct regular status update calls with Call Center vendor, Global Medical Information and partners as applicable to facilitate transparency and coordination.
- Proactively analyze and communicate insights based on US Medical Information queries.
- Provide accurate and insightful reports of Medical Information queries to US Medical Directors, the Medical and Scientific Affairs team and partners as applicable.
- Provide ongoing support to the Global Medical Information team and serve as the main point of contact for the development and review of local resources and materials.
- Optimize processes and procedures related to Medical Information to ensure quality and performance.
Serve as Local Drug Safety Responsible for US Medical and Scientific Affairs
- Be source of literature ; papers by request from team members.
- Ensure all members of the US organization and its designees (as appropriate) have completed all required pharmacovigilance training and maintain accurate records of such.
- Ensure processes and procedures are in place for the collection of relevant safety data from various sources from the US organization (i.e., NIS, Market Research, etc.).
Serve as Medical Reviewer on MRC Committee
- Perform thorough, accurate and timely review of medical materials in the MRC process.
- Highlight areas for improvement or correction and ensure resolution of medical comments on final pieces.
Scientific Writing and Content Development for Ad Hoc Projects
- Support projects such as product dossiers or slide decks with content development/medical writing expertise.
The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience, and knowledge, or the equivalent:
- Advanced degree in related field (PharmD, PhD, MD/DO, etc.).
- 5 years of experience directly managing the Medical Information function in pharma.
- Direct experience managing Medical Information call centers, vendors, and partner organizations.
- Experience with and working knowledge of regulatory processes and pharmaceutical compliance.
- Must be experienced with word processing, spreadsheet and database applications, including MS Project and MS Office (Word, Excel, PowerPoint, Outlook).
- Experience with Medical Information databases (e.g., IRMS) and medical review systems (e.g., VeevaVault).
- Some travel may be required (~5-10%).
- 5+ years of Medical Information and project management responsibilities.
- Experience with and working knowledge of the drug development.
- Experience in nephrology.
As a federal contractor, Vifor Pharma, Inc. is required to comply with Executive Order 14042, which requires all employees to be vaccinated against COVID-19 absent a bona fide medical reason, a genuine religious belief, on an individual basis in accordance with applicable legal requirements. All employees must be in compliance with Vifor Pharma, Inc.’s COVID-19 vaccine policy at the commencement of their employment.