Vice President, Head of Safety & Pharmacovigilance
About the Company
Pioneering biotechnology company
Industry
Biotechnology
Type
Privately Held
About the Role
The Company is seeking a VP, Head of Safety and Pharmacovigilance to play a pivotal role in the organization's commitment to patient safety and the integration of safety into all aspects of the drug development process. The successful candidate will be responsible for leading and building out the safety and risk management function, ensuring strategic oversight and execution of all safety and pharmacovigilance activities, and maintaining compliance with global regulatory standards. This includes establishing a safety and pharmacovigilance infrastructure that prioritizes safety by design, leading safety surveillance, signal detection, and risk-benefit assessments, and serving as the primary contact for safety-related issues. Applicants must have an M.D., D.O., or M.B.B.S. with a minimum of 10 years of global experience in drug safety within the biotechnology or pharmaceutical industry. In-depth knowledge of FDA safety regulations, ICH Guidelines, EU GVP, and other global safety regulations is essential, as is expert knowledge of safety database applications and signal detection. The role requires strong leadership skills, the ability to mentor teams, and excellent communication skills to influence senior leadership and external stakeholders. The VP, Head of Safety and Pharmacovigilance will also be responsible for managing the pharmacovigilance budget and resources, driving continuous improvement in pharmacovigilance practices, and collaborating with cross-functional teams to integrate safety considerations into the company's strategy.
Hiring Manager Title
Chief Medical Officer
Travel Percent
Less than 10%
Functions
...safety and regulatory compliance. Position Overview: The Social Media Manager will enhance Sesh's brand presence across social platforms by... ...: Competitive salary and benefits. A dynamic, creative work environment with opportunities for growth. The chance to...
...rooms.Back ground check process and Work Authorization Mandatory.Flexible schedule and need to help sometimes Front desk tasks and required cleaning areas.Accommodation Provided for 1 person only.Please send Email with full details.Los Angeles Location,Near DTLA.
...the course of medical care. Assumes clinical evaluation, intervention and planning for patients with complex psychosocial risk (homelessness, protective services, frail elderly, disabled, psychiatric and substance abuse, etc.). Works effectively as part of interdisciplinary...
...include Responsible for providing clinical consultations, evaluations, and rehabilitation programming for individuals at the Center for Autism. Services may include: preliminary screening of individual needs for OT intervention, ADL and clinical evaluation and treatment,...
...Team Clinical Services Working time Part-Time Description & Requirements Description INTERCARE is now HIRING for AFTER SCHOOL positions in Orange County! ENJOY FLEXIBLE HOURS & PAID TRAINING! Looking for applicants who are available from 3pm-6pm Monday...