Senior Lead PV Science

### Responsibilities - Manage internal PV personnel and external resources, including full oversight of all PV vendor activities to ensure operational excellence and compliance. - Build and mentor a high-performing pharmacovigilance team, fostering a culture of scientific rigor, accountability, and continuous improvement. - Oversee day-to-day case processing and global safety monitoring activities for assigned products across all phases of clinical development. - Ensure timely, accurate assessment and reporting of adverse events and emerging safety signals. - Lead and facilitate cross-functional safety governance meetings, including coordination of materials, agenda planning, data presentation, documentation of decisions, and tracking safety-related action items. - Provide PV subject matter expertise on Program Teams and cross-functional working groups throughout the company. - Contribute to the development and maintenance of core PV and safety governance documents, including Safety Management Plans (SMPs), safety data exchange agreements (SDEAs), and PV-related SOPs, work instructions, and process guides. - Drive continuous improvement and inspection readiness across PV processes. - Support strategic benefit-risk assessments and safety communication planning. ### Required Skills - Bachelor's degree required with at least 10 years of industry experience, including a minimum of 8 years focused on clinical/safety and demonstrated PV expertise. - Professional health background (RN, PharmD, MD) highly preferred. - Knowledge of global safety regulations, MedDRA terminology, and principles of data entry and data extraction with global safety databases. - Experience reviewing cumulative safety data with the ability to interpret, synthesize, communicate, and present complex clinical/pharmaceutical information. - Demonstrated experience in the preparation and authoring of pre- and post-aggregate safety reports. - Thorough understanding of the drug development process and context applicable to safety surveillance activities. - Ability to work effectively in a collaborative team environment and influence across multiple functions. - Ability to alert the Medical Safety Physicians or Medical Monitors to potential safety issues identified through single case medical review or aggregated datasets. - Excellent organizational, written, and verbal communication skills.