Associate Director, Patient Safety- Virology

Gilead Sciences • Foster City, CA

2d • $195,670 - $253,220 • Remote

About The Position

The Associate Director, Patient Safety-Virology provides strategic pharmacovigilance leadership for one or more products, compounds, or indications across the development and/or post‑marketing lifecycle. This role contributes safety expertise to ensure continuous evaluation of benefit–risk profiles, regulatory compliance, and patient safety, while serving as a key Patient Safety representative on cross‑functional teams. The Associate Director operates with a high level of autonomy, partnering across functions to support product development, lifecycle management, and post‑authorization safety activities.

Requirements

• PharmD/PhD with 2+years’ relevant experience. MA/MS/MBA with 8+ years’ relevant experience. BA/BS with 10+ years’ relevant experience.
• Relevant experience in pharmacovigilance / patient safety within the pharmaceutical or biotechnology industry
• Working knowledge of global pharmacovigilance regulations and aggregate safety reporting requirements
• Demonstrated ability to evaluate safety data, apply clinical judgment, and communicate benefit–risk considerations
• Experience working effectively in cross‑functional, matrix environments.

Nice To Haves

• Experience supporting safety oversight for products across multiple stages of the development or post‑marketing lifecycle
• Prior involvement in safety signal evaluation, risk management activities, and regulatory interactions
• Strong written and verbal communication skills with the ability to present complex safety information to diverse stakeholders
• Ability to manage multiple priorities and products concurrently in a fast‑paced environment

Responsibilities

• Provide scientific input into pharmacovigilance activities, including safety surveillance, signal detection and evaluation, and benefit–risk assessments for assigned products and assisting with pharmacovigilance activities for other products when needed
• Contribute to the development and execution of safety strategies across the product lifecycle from clinical development through post‑marketing
• Provide input into aggregate safety reports (e.g., PSURs/PBRERs, DSURs), regulatory submissions, and responses to health authority inquiries
• Support risk management activities, including Risk Management Plans, risk minimization measures, and safety‑related labeling updates.
• Contribute to activities related to regulatory filings and responses to safety queries from third parties, such as regulatory agencies, as needed
• Review of clinical study protocols, amendments, and study‑related documents
• Represent Patient Safety on cross‑functional teams, collaborating with Clinical Development, Regulatory Affairs, Medical Affairs, RWE/HEOR, and other functions
• Ensure pharmacovigilance activities are conducted in compliance with global regulations, internal SOPs, and quality standards
• Contribute to inspection readiness, process improvement initiatives, and the ongoing enhancement of Patient Safety operating models
• Build effective working relationships and provide thoughtful safety input to internal stakeholders to support patient‑centric decision‑making

Benefits

• company-sponsored medical, dental, vision, and life insurance plans
• discretionary annual bonus
• discretionary stock-based long-term incentives
• paid time off

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level