Associate Director, Patient Safety- Virology

About the role

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.

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
• 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

Requirements

• PharmD/PhD with 2+ years’ relevant experience
• MA/MS/MBA with 8+ years’ relevant experience
• Bachelor’s degree in a relevant field 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

Qualifications

• Education: PharmD/PhD, MA/MS/MBA, BA/BS

Experience: 2+ years’ relevant experience for PharmD/PhD, 8+ years’ relevant experience for MA/MS/MBA, 10+ years’ relevant experience for BA/BS

Preferred Qualifications:

• 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

Salary Range: Bay Area: $195,670.00 - $253,220.00. Other US Locations: $177,905.00 - $230,230.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary.

Benefits: Company-sponsored medical, dental, vision, and life insurance plans*

Equal Opportunity Employer: Gilead Sciences is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, and U.S. Citizenship is required for most positions. Applicants who require reasonable accommodation to complete any part of the application process due to a disability should contact us to request such accommodation. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.