Associate Director, Patient Safety- Virology
Core
Strategic pharmacovigilance leadership ensuring continuous evaluation of benefit-risk profiles, regulatory compliance, and patient safety for one or more products across the development and post-marketing lifecycle.
Role type
Associate Director, Pharmacovigilance
Builds
Safety strategies, aggregate safety reports, regulatory submissions, and risk management plans for pharmaceutical products.
Domain
Pharmaceutical / Biotechnology / Patient Safety
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmacovigilance expertise, benefit-risk assessment, global regulatory knowledge, safety data evaluation, cross-functional collaboration, inspection readiness
Preferred skills
Multi-stage lifecycle safety oversight, safety signal evaluation, risk management activities, regulatory interactions
Technologies
PSURs/PBRERs, DSURs, Risk Management Plans
Responsibilities
Provide scientific input into safety surveillance, signal detection, and benefit-risk assessments; contribute to safety strategies from clinical development through post-marketing; provide input into aggregate safety reports and regulatory submissions; support risk management activities including labeling updates; review clinical study protocols and amendments; represent Patient Safety on cross-functional teams; ensure compliance with global regulations and internal SOPs.
Seniority
Senior, strategic leadership with hands-on technical input
