Drug Safety Associate
280 East Grand Avenue South San Francisco, CA 94080
Bayside Solutions is seeking a Drug Safety Associate to be a part of our Client’ s team in South San Francisco. This is a unique opportunity to join a growing team of professionals focused on the treatment of diseases that affect the functionality of an individual.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Drug Safety Associate
- Opportunities to grow and develop within Drug Safety; training from a team of experienced professionals.
- Competitive compensation and work-life balance.
- This position is eligible for medical, vision, and dental benefits, paid sick time and 401k.
Summary of Responsibilities:
- Triages and maintains the Drug Safety box
- Updates and distributes list of pending cases to Safety team
- Updates and maintains the SAE tracker
- Updates and maintains the Case description tracker for medical monitors
- Maintains the Drug Safety folder in the shared drive
- Assists in preparing the monthly SAE listing for distribution to the DMC
- Serves as first level of Quality Control for draft case narratives and queries prior to sending to Drug Safety Manager (DSM) for second QC
- Sends notification receipt emails to Parexel
- Assists the DSM in maintaining Issues log with vendors, etc.
- Assists in preparing ad hoc reports
- Sends the BLINDED MedWatch report to CK Regulatory (all reports) and DMC (Initials only) after DSM’ s review and approval
- Degree in life sciences. Health care professional (pharmacy, nursing or equivalent) is strongly preferred
- 3 to 5 years of experience in drug safety is strongly preferred
- Knowledge of adverse event regulatory reporting requirements
- Experience with drug safety databases, case processing and MedDRA coding concepts
- Attention to quality focusing on details with enthusiasm toward ways to improve processes
- Demonstrated ability to work effectively, collaboratively under minimal supervision with a sense of urgency in a dynamic, cross-function matrix environment
- Ability to solve complex problems and set priorities to complete work
- Proficiency in the use of relevant computer systems including MS Word, Excel, PowerPoint, and Outlook
- Safety data base knowledge preferred
- Strong interpersonal, written and oral communication skills and professionalism