Associate Director, Patient Safety-Virology

Job title: Associate Director, Patient Safety-Virology

About the Role

The Associate Director, Patient Safety-Virology provides strategic pharmacovigilance leadership for one or more products across development and/or post-marketing lifecycle, contributing to continuous evaluation of benefit–risk, regulatory compliance, and patient safety with autonomy in cross-functional teams.

What You'll Do

• Provide scientific input into pharmacovigilance activities, including safety surveillance, signal detection and evaluation, and benefit–risk assessments for assigned products, and assist with pharmacovigilance activities for other products when needed.
• Contribute to development and execution of safety strategies across the product lifecycle from clinical development through post‑marketing.
• Provide input into aggregate safety reports, 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 ongoing enhancement of Patient Safety operating models.
• Build effective working relationships and provide safety input to internal stakeholders to support patient‑centric decision‑making.

What We're Looking For

• 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.
• People Leader Accountabilities: Create Inclusion, Develop Talent, Empower Teams.

Nice to Have

• Experience supporting safety oversight for products across multiple stages of 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.