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Senior Medical Review Specialist
2 months ago
Gilead Sciences is seeking a highly skilled Medical Review Director to join our team. As a key member of our organization, you will be responsible for overseeing the medical review of individual case safety reports (ICSRs) and line listings for marketed and investigational products.
Key Responsibilities- Establish and maintain recognition as an expert on medical safety assessment of individual cases and line listings.
- Perform peer retrospective quality control (QC) of adverse event reports from a medical review perspective.
- Participate in internal and external educational initiatives to stay up-to-date on the latest medical review practices and regulations.
- Initiate, lead, or contribute to functional or cross-functional projects to improve medical review processes and standards.
- Collaborate with global safety leads and global safety strategy leads on select cases with suspected unexpected serious adverse reactions (SUSARs) from clinical trials.
- May serve on higher-level intradepartmental and interdepartmental cross-functional projects.
- May lead or contribute to the development and maintenance of procedural documents and provide training to junior staff.
- Support internal and external audit and inspection activities.
- Provide medical consultation to the Patient Safety (PS) Strategic Operations group on an ad hoc basis.
- Provide mentorship and training to junior staff, new hires, and contractors to independently review adverse event reports for investigational and marketed products.
- Respond to medical review-related questions from other functions in a timely manner.
- Make contributions to process improvement within PS, particularly with adverse event processing and operational aspects of medical review.
- May recruit, hire, mentor, and manage direct reports, with responsibility for team members' performance evaluations.
- Participate in biweekly Medical Review team meetings.
- Provide medical input to Strategic Operations on case queries.
- Play a leadership role by providing medical review support for other functional groups.
- Make significant contributions to the ongoing development and refinement of medical review processes, standards, practices, efficiencies, and capabilities.
- Direct and oversee the development of new procedures and relevant medical review strategies.
- Ensure meticulous adherence to deadlines and anticipate events that might impact deadlines.
- Oversee the development of medical review activities and inform management decision-making.
- May participate as Medical Review representative in audits/inspections.
- When needed, prioritize work and delegate to other MR colleagues.
- Lead internal MR projects and represent MR on cross-functional projects.
- Ensure appropriate and timely collaboration between MR and other groups for medical review activities.
- May have one or more direct reports.
- Provide accurate and thorough input and recommendations into resource plans required to complete own deliverables.
- Ensure own work complies with established practices, policies, and processes, and any regulatory or other requirements.
- Requires an MD/DO degree or equivalent.
- Requires completion of an accredited medical or surgical residency program. Board certification is preferred.
- Should have either (1) minimum of 4 years' experience in medical review or (2) an applicable role in the pharmaceutical industry with a general understanding of relevant regulatory requirements or an exceptional track record of excellence in clinical practice.
