Associate Director, Drug Safety Scientist (RE-12451905) Berkeley, California

Salary: USD130 - USD155 per hour

Associate Director, Drug Safety Scientist

A pharmaceutical company in South San Francisco is looking for an Associate Director, Drug Safety to join their team. 

Associate Director, Drug Safety Scientist Responsibilities: 

  • Interprets, evaluates, and analyses individual case safety reports
  • Interprets, evaluates, and analyses aggregate safety data
  • Develops written safety data analyses
  • Develops signal detection and recommends actions
  • Participates in risk management activities  
  • Recommends product labeling changes based on review and analysis of safety data
  • Responds to regulatory authority inquiries
  • Assists with special projects 
  • Provides scientific expertise and oversight
  • Participates in recruitment and selection of additional personnel
  • Ensures compliance with business agreements and regulatory requirements
  • Is a liaison with business partners, vendors and regulatory authorities 
  • Mentors internal resources
  • Trains external audiences 
  • Serves as project lead for assigned projects
  • Develops department policies and guidelines

Associate Director, Drug Safety Scientist Requirements:

General Skills

  • Experience with computer based applications (e.g., Microsoft Word, Excel, PowerPoint)
  • Detail oriented
  • Excellent interpersonal and organizational skills
  • Excellent written and verbal communication skills
  • Ability to work proactively
  • Excellent problem solving skills 

Specific Skills

  • Knowledge of and ability to interpret and apply international safety regulations
  • Demonstrated competence in collecting, analyzing, and reporting safety data in compliance with regulations
  • Experience preparing investigational and postmarketing regulatory reports
  • Experience developing data analyses and medical evaluation of safety data
  • Experience with pharmacovigilance related computer systems and programs
  • Experience managing people and teams
  • Excellent leadership skills 

Education & Experience

  • RN/MS, PharmD, MD with 5+ years pharmacovigilance experience

If you are interested in applying to this role, please respond to this job posting ASAP to be considered.