Description
Summary- Oversees the processing and reporting of safety information cases
- Responsible for the preparation, analysis, and follow-up of AE and SAE reports from post marketing or clinical sources.
- Assures data accuracy, clinically valid case assessment and regulatory reporting status assessment
- responsible for the reconciliation of the safety database
- Ensures and contributes to the mentoring and training of new colleagues
- Hire, train and mange staff
Key Duties and Responsibilities
- ICSR Processing
- SAE Reconciliation
- Process Project and System Support
- SOP Development and Training
- People management
Education
- Bachelors of Science + 9 years of Drug Safety experience and 1-2 years leadership experience preferred
- Masters degree + 7 years of Drug Safety experience and 1-2 years of leadership experience
- PhD + 5 years of Drug Safety experience
Essential Skills and Abilities
- Good knowledge of medical terminology
- Working knowledge of relevant regulations and guidance documents governing both safety reporting and processing for clinical trial and post-marketing environment
- Computer proficiency and computer data entry experience
- Strong organizational skills, detail oriented, ability to adapt in a fast paced constantly changing environment
- Clear, effective written and verbal communication skills
- Ability to work under pressure in order to meet tight deadlines
- Good interpersonal skills
To find out more about Real please visit www.realstaffing.com