What are the responsibilities and job description for the Drug Safety Associate position at BioDelivery Sciences International, Inc.?
OVERVIEW
The Drug Safety Associate reports to the Director, Drug Safety and Pharmacovigilance and the responsibilities include performance of triage, data entry, case processing, quality control, workflow management, data retrieval and other administrative duties, as assigned.
RESPONSIBILITIES
Perform data entry of individual case safety reports (ICSRs), including narrative writing
Triage incoming cases for daily workflow management
Perform quality control activities to ensure complete and accurate case information
Perform data retrieval from the safety database, as needed
Perform database reconciliation of AE/SAE, product complaints in collaboration with vendors
Support generation of aggregate safety reports (PADERs)
Other administrative duties, as assigned
QUALIFICATIONS
- Education: BS/MS degree in a health and life sciences related fields, preferably Pharmaceutical Science, Regulatory Science, Biology, Chemistry, Microbiology, biochemistry
- 1-3 years post-marketing drug safety/drug development or relevant experience
- Knowledge of safety databases (ArisG experience is a plus)
- FDA Industry Guidelines, ICH Guidelines
- Knowledge of pre- and post-marketing pharmacovigilance
- Technical expertise and an excellent working knowledge of Microsoft Office: PowerPoint, Word, Excel, share sites
- Good written and oral communication skills
- Working knowledge and familiarity with medical terminology including MedDRA coding
- Ability to work collaboratively as part of a team.
- Self-motivation and the ability to drive results independently
- Excellent organizational and problem-solving skills
PEOPLE MANAGEMENT RESPONSIBILITIES
None- Individual Contributor Role
None- Individual Contributor Role
PHYSICAL DEMANDS
Work is typically performed in an office
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