Assoc. Director/Director Drug Safety (Pharmacovigilance)

Position Overview

 

To ensure that the PV dept is appropriately portrayed to cross functional department management. Ensures continual PV process improvement in accordance with local and international regulations. Communicates with and maintains client relationships. Responsible for the development of business practices and associated proposal and contract review. Reviews and/or develops regulatory reports and clinical protocols and other related documents.  Monitors PV management activities and provides feedback and performance reviews. 

 

 

Duties/Responsibilities

 

· Ensure PV practices are complete and up to date with appropriate regulations

· Ensure team members are trained to appropriately evaluate reports for serious criteria and

  compliance with reporting requirements according to SOP, ICH, and Federal Regulations

· Plan and implement project teams according to schedules and need

· Set expectations of individual projects

· Establish and maintain effective communicate with project sponsor

· Provide direction and support of PV members on cross functional teams

· Review and provide comment on regulatory agency reports

· Provide comment on clinical documents (protocols, manuals, IB) regarding safety topics

· Identify need for additional training materials, work instructions, SOPs, and department

  procedures where applicable

· Provide feedback as needed and annual performance review of PV personnel

· Develop proposals and contracts as appropriate for business development

 

 

Position Qualifications

 

· Advanced degree (health care related field preferred)

· 8 years experience (or demonstrated ability) in drug safety or related field, health care related

  experience desirable

· Thorough understanding of GCP, ICH, and applicable regulations

· Excellent written and verbal communication skills

· Detail-oriented with excellent organizational skills

· Understands medical terminology and demonstrates knowledge of coding dictionaries

· Strong interpersonal skills



Other Skills/Abilities

· Demonstrates leadership capacity

· Proficiency in standard word processing, spreadsheet and database packages

· Critical thinking and problem solving

· Time management skills

 

 

This job description is intended as a summary of the primary responsibilities of and qualifications for this position.  The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all the qualifications that may be required either now or in the future.

 

Please send your resume to resume@clinquest.com and visit our website at www.clinquest.com.

 

Clinquest is a small but growing biotech consulting company.  We specialize in providing product development advice and services to biotech and pharmaceutical companies.

 

Because we are a small group, we are looking for someone who is very dedicated.  Our projects are challenging and require creativity and intelligence.  Within Clinquest, you will help build internal systems used to support our growth.  Clinquest's corporate management philosophy is meant to nurture a dynamic and entrepreneurial atmosphere.