Drug Safety Associate (contract)
280 East Grand Avenue South San Francisco, CA 94080
Drug Safety Associate
Late-stage biopharmaceutical company focused on discovering, developing, and commercializing first-in-class muscle activators as potential treatments for people with debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology research, we’ re developing small molecule drug candidates specifically engineered to increase muscle function and contractility. We take a purpose-driven approach by leveraging our unique muscle biology expertise to engineer compounds with specific characteristics aimed at treating diseases that impact muscle function, like heart failure, ALS and SMA.
We view our employees as the unequivocal ingredients to success. Each and every employee is an integral member of the team, contributing to our shared goal of improving lives. While expectations of our employees are high, there is an equal commitment to ensuring that contributions are recognized and rewarded. We seek exceptional individuals to join us in our mission to develop the next generation of novel small molecule drugs specifically engineered to increase muscle function and contractility.
This is for a 3-6 months contract with a possibility to be a contract-to-hire opportunity.
- 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
 Title commensurate with experience