Senior Lead, PV Science and Operations

Role Overview

• Manage internal PV personnel and external resources, including full oversight of all PV vendor activities to ensure operational excellence and compliance.
• Build (where applicable) 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.

Requirements

• 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 its application, 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 execute and follow through to completion.
• Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
• Ability to alert the Medical Safety Physicians or Medical Monitors to potential safety issues identified through single case medical review or aggregated datasets.
• Independently motivated, detail-oriented, and possessing good problem-solving ability.
• Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
• Excellent written and verbal communication skills and ability to influence across multiple functions.
• Ability to assist with first line clinical/medical data review to support medical monitoring activities.

Benefits

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short
• and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation