Senior Medical Director, PVRM

This is a fully remote position, open to applicants in United States.

📋 Description

• Direct the safety strategy and key communications in NDA/BLA/MAA submissions.

• Oversee continuous safety monitoring of designated investigational and marketed products.

• Provide PVRM Medical representation during product-specific and/or clinical study team meetings and governance committees.

• Prepare and deliver safety data analyses to project teams and senior management for assigned products.

• Assess safety data and contribute to or 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).

• Assist in the preparation and updating of Company Core Data Sheets (CCDS) and local labels such as the 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).

• Conduct medical reviews of Aggregate Reports (PADER, PSUR, PBRER, DSUR, IND/NDA Annual Reports).

• Manage Health Hazard Evaluations and respond to Ad-Hoc Regulatory safety inquiries.

• Execute aggregate safety data reviews to support signal and trend detection activities, safety evaluation/analysis/investigation, risk-benefit management, and other departmental activities as necessary.

• Engage in additional activities such as literature evaluations, investigator site training, continuing education for internal staff, audits, and inspections.

• Cultivate and maintain strong relationships with cross-functional teams including Clinical Development, pre-clinical Safety, Clinical Operations, and Clinical Pharmacology.

• Keep abreast of applicable global regulatory authority regulations.

• Assist PVRM or cross-functional ad-hoc projects or assignments that require safety insights.

• Ensure adherence to regulations/internal SOPs and promote a “Patient first” culture in alignment with SMPA’s values and related behaviors.

• Ensure 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 within the biotech or pharmaceutical industry.

• Experience in Oncology and Neurology is desirable.

• Familiarity with NDA/BLA/MAA submissions.

• Previous experience in people management.

🏝️ Benefits

• Merit-based salary increases.

• Participation in a short incentive plan.

• Eligibility for our 401(k) plan.

• Comprehensive medical, dental, vision, life, and disability insurance options.

• Flexible paid time off.

• 11 paid holidays.

• Additional time off during the last week of December for a shutdown period.

• 80 hours of paid sick time upon hire and each year thereafter.