Senior Director, Head of PV Science
Core
Leading the Pharmacovigilance (PV) Science department and Aggregate Reports team to manage safety profiles, regulatory submissions, and risk management systems for RNAi therapeutic medicines.
Role type
Senior Director, Head of PV Science and Aggregate Reports
Builds
Safety aggregate reports (DSURs, PSURs), Risk Management Plans, and operational PV processes for investigational and marketed products.
Domain
Biopharmaceuticals / RNAi therapeutics / Drug Safety
Deliverable
client delivery
Required skills
Strategic leadership, Pharmacovigilance regulatory expertise, Safety operations management, Process improvement, Budget management, Regulatory inspection readiness, Argus Safety Database proficiency, Global regulatory knowledge (US, EU, LATAM, APAC)
Preferred skills
RNAi therapeutics experience, Rare disease experience, Matrix environment navigation, Cross-cultural collaboration
Technologies
Argus Safety Database, Empirica, PV Analytics
Responsibilities
Manage PV Scientists and Aggregate report specialists; Oversee production and submission of DSURs and PSURs; Lead development of SOPs and training activities; Provide scenario planning and budget forecasting; Oversee safety committee activities (SRMT, ESB); Ensure timely completion of action items and audit readiness.
Seniority
Senior Director, strategic leadership & team management
