FEATURED OPPORTUNITY

Senior Director/ Director of Drug Safety

Outstanding opportunity for a Senior Director/ Director of Drug Safety at one of the nation’s pioneering biotech companies! You will work on first-in-class biopharmaceuticals in oncology and regenerative therapeutics, advancing anti-cancer efforts to groundbreaking new heights.

 

As the Senior Director/ Director of Drug Safety, you will be an experienced expert in drug safety regulations who will make confident decisions, determine and define the REMS and safety medical implications, and have the operations savoir-faire to oversee CRO's authority on SOPs. You will have the opportunity to cultivate risk management strategy, and will play a critical part of the drug development team, working on drug safety issues for first-in-kind products.

Responsibilities include:

·         Medical review of SAE & PMAEs for clinical content & case coding in MedDRA

·         Triage for appropriate causality assessment on Individual Case Safety Report (ICSRs) for regulatory reporting

·         Communication with external individuals (Consumers/CROs/Clinical Sites/Health Care Professionals /Regulatory Authorities) as necessary

·         Contribute to development and maintenance of product safety profile

·         Facilitate/advise on SOP/TM creation

·         Advocate and actively support regulatory/safety compliance

·         Provide expertise and guidance on teams for interdepartmental and cross-functional teams

Required:

·         MD, U.S. licensure or U.S. board certification, drug safety experience

This company is a genuine innovator in biopharmaceuticals. They are extremely well funded and financially stable due to their one-of-a-kind biotechnologies.

 

Compensation: Highly competitive and comprehensive

Contact:
Amanda DeSalvatore
Project Manager
Avant Executive Solutions, LLC
amandad@avantexec.com