Associate Director, Patient Safety in Newtown

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 for other products when needed.
• Develop and execute safety strategies across the product lifecycle from clinical development through post‑marketing.
• Contribute to 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.
• Respond to safety queries from third parties such as regulatory agencies and support regulatory filings.
• Review 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 comply 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.
• Model inclusion and embed the value of diversity within the team’s management practices.
• Develop talent by understanding employees’ skills and aspirations and coaching on current performance and future potential.
• Empower teams by aligning goals with organizational objectives and removing barriers to success.

Qualifications

• PharmD/PhD with 2+ years of relevant experience, or MA/MS/MBA with 8+ years, or BA/BS with 10+ years of 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.

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.