Pharmacovigilance Risk Management (PVRM) Medical Director

Role Summary

The PVRM Medical Director is responsible for the medical review of Individual Case Safety Reports (ICSRs) for Exelixis products and is involved with other safety deliverables for assigned project(s). The role collaborates closely with Drug Safety Operations staff and Clinical Development, supports regulatory compliance with pharmacovigilance regulations, safety signal detection/management, and contributes to the overall benefit-risk management of Exelixis products.

Responsibilities

• Perform medical review of ICSRs for assigned product(s) in clinical development or for marketed products
• Ensure that ICSRs contain accurate medical content through appropriate querying and obtained source data verification
• Collaborate closely with Drug Safety staff providing medical expertise and guidance for proper gathering, evaluation, medical assessment, and follow-up of ICSRs
• Review and/or Author an Analysis of Similar Events (ASE) for expedited cases
• Identify clinically important cases and lead the discussion on such cases by liaising with the medical monitor of the respective clinical study to discuss next steps
• Review global literature for assigned products for identification of ICSRs and assess their reportability
• Contribute to aggregate safety data reviews, signal evaluation, interpretation and documentation for assigned project(s) or product(s)
• Provide medical input in the development and maintenance of RMPs for assigned product(s)
• Contribute to science sections of the aggregate reports for assigned product(s)
• Provide medical input for the Reference Safety Information (RSI) for assigned product(s)
• Contribute/lead, participate and support Benefit-Risk Team meetings for assigned project(s) and product(s)
• Provide safety input in study protocols, study reports or high-level summary documents for regulatory filings for assigned project(s) or product(s)
• Prepare and present safety data for Data Monitoring Committees for specified project(s) or product(s)

Qualifications

• M.D. degree required and a minimum of 5 years of experience post-residency with at least 2+ years of clinical experience post-residency; or equivalent combination of education and experience
• Completion of an accredited medical or surgical residency program is required. Board certification is preferred
• Experience: High level of medical competence with 5+ years in a medical review role in the pharmaceutical industry; oncology experience preferred

Skills

• Extensive knowledge of biotechnology/pharmaceutical sector drivers and practices
• Knowledge of international regulations, guidance and initiatives governing clinical trial and post-marketing safety environments
• Advanced ability to gather, sort and apply key information to solve problems
• Strong organizational and planning skills; ability to manage time, workload and resources
• Ability to lead and manage a team to achieve objectives
• Clear and effective verbal and written communication; ability to present to cross-functional groups
• Collaborative mindset; ability to engage stakeholders and build relationships
• Interpersonal skills to reconcile differing views and reach resolutions
• Develops procedures, trains staff, and mentors junior team members

Education

• M.D. degree required (Board certification preferred)

Additional Requirements

• No supervisory responsibilities