Senior Lead, PV Science and Operations, WCH

About This Role: As a Senior Pharmacovigilance (PV) Lead, you will provide strategic and operational PV/safety support for Biogen’s West Coast Hub development programs, working closely with cross-functional colleagues. This Director level position is pivotal in overseeing global safety operations, ensuring high-quality pharmacovigilance deliverables, and offering expert guidance across the organization. You will manage internal and external PV resources, lead cross-functional safety governance, and serve as a subject matter expert for safety strategy across clinical development, regulatory filings, and post-marketing activities. This role is integral to the business structure, fostering collaboration and advancing the strategic safety objectives of the organization.

What You’ll Do:

• 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.

Who You Are: You are highly collaborative and detail-oriented, thriving in a dynamic environment where vendor oversight and complex PV program management are critical. Your ability to incorporate multiple perspectives facilitates effective teamwork and problem-solving. You possess an innate drive for continuous improvement and a commitment to scientific rigor, making you an invaluable leader in your field. Your strong communication skills enable you to influence across various functions, ensuring the successful navigation of safety challenges.

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 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.

Preferred Skills:

• Experience with inspection readiness and continuous improvement initiatives.
• Familiarity with strategic benefit-risk assessments.
• Strong leadership skills in cross-functional safety governance settings.

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Additional Information