Senior Medical Director, PVRM

Role Overview

• Lead safety strategy and key messaging in NDA/BLA/MAA submissions
• Lead ongoing safety monitoring of assigned investigational and marketed products
• Providing PVRM Medical representation on product specific and/or clinical study team meetings and governance committees
• Prepare and present safety data analysis to project teams and senior management, for assigned products
• Evaluate safety data and contribute/author safety sections as a medical safety subject matter expert (SME) on behalf of PVRM for: Study Protocols, Informed Consent Forms (ICF), Safety Management Plans (SMP), Clinical Study Reports (CSR), and Investigator’s Brochures (IB)
• Contribute to preparation and update of Company Core Data Sheets (CCDS), Locally labels such as, United States Prescribing Information (USPI), European Summary of Product Characteristics (SmPC), Canadian Product Monograph (PM), and Risk Management Plans (RMPs)/Risk Evaluation and Mitigation Strategy (REMS)
• Medical review of Aggregate Reports (PADER, PSUR, PBRER, DSUR, IND/NDA Annual Reports)
• Handle Health Hazard Evaluations and Ad-Hoc Regulatory safety inquiries
• Perform aggregate safety data review in support of signal and trend detection activities, safety evaluation/analysis/investigation, risk benefit management and other departmental activities as appropriate
• Participate/contribute to other activities such as literature evaluation, investigator site training, continuing education for internal staff, audits, and inspections
• Develop and maintain strong relationship with cross-functional teams such as Clinical Development, pre-clinical Safety, Clinical Operations and Clinical Pharmacology
• Maintain a working knowledge of applicable global regulatory authority regulations
• Support PVRM or cross-functional ad-hoc projects or assignments that require safety input
• Ensure compliance with regulations/internal SOPs and fosters a culture of “Patient first” in line with SMPA’s values and related behaviors
• Ensures timely and quality review and assessment of ICSRs, including seriousness, expectedness, safety narratives, adverse event coding, concomitant medication coding, and causality statements

Requirements

• Medical Degree (MD)
• 12+ years of relevant experience in biotech or pharmaceutical industry
• Experience in Oncology and Neurology is preferred
• Experience with NDA/BLA/MAA submission
• Prior people management experience

Benefits

• merit-based salary increases
• short incentive plan participation
• eligibility for our 401(k) plan
• medical, dental, vision, life and disability insurances
• flexible paid time off
• 11 paid holidays
• additional time off for a shut-down period during the last week of December
• 80 hours of paid sick time upon hire and each year thereafter