Description
Senior Director / Director, Drug SafetyA pharmaceutical company in the Berkeley, CA area is looking for a Senior Director/Director, Drug Safety to join their team. This is an exciting opportunity to join a growing company.
Senior Director Drug Safety Responsibilities:
- Oversees the interpretation, evaluation, and analysis of individual case safety reports
- Oversees the interpretation, evaluation, and analysis of analyze aggregate safety data
- Oversees development of written safety data analyses
- Oversees 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
- Manages personnel
- Aligns internal resources with projects and work load
- Sets internal team priorities
- Works with management team to set performance expectations and goals for personnel
- Provides on-going feedback to employees, and documents feedback
- Fosters teamwork and collaboration
- Communicates information in to the team
- Ensures team members have access to tools and resources
- Demonstrates accessibility and availability to all team members
- Works with personnel to plan and implement their career development
- Participates in budget development
Senior Director Drug Safety 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
- Willingness to mentor others
Education & Experience
- MD with 8+ years pharmacovigilance experience
If you are interested in applying to this role, please respond this job posting with an updated version of your resume at your earliest convenience as we are looking to identify a candidate immediately.
To find out more about Real please visit www.realstaffing.com