Ardea Biosciences, a wholly owned subsidiary of AstraZeneca, is headquartered in San Diego, CA. We are a biotechnology company focused on the development of small-molecule therapeutics for the treatment of serious diseases.
Ardea Biosciences is searching for a Pharmacovigilance Associte to join the team. This person will be responsible for the pharmacovigilance activities for investigational products. Duties may include but are not limited to tracking all Serious Adverse Event (SAE) activity, drafting letters to the US Investigators for reportable cases, and general liaising with pharmacovigilance vendors as it pertains to SAE case processing.
Primary Duties and Responsibilities
- Review and update SOPs related to pharmacovigilance activities at Ardea
- Review and update Safety Plans including SAE forms and instructions for Ardea clinical studies
- Review relevant safety sections of the Development Core Safety Information during annual review
- Assist with coordination and compilation of the Development Safety Update Report for annual submission
- Assist in the preparation of the safety summaries as requested for data monitoring and/ or adjudication purposes
- Liaise with pharmacovigilance vendor(s)
- Track case processing activities
- Assist with reconciliation processes between clinical and safety databases
- Assist with the First Point Pharmacovigilance Library maintenance
- Train Clinical Development Staff on SAE reporting requirements
- Other responsibilities as appropriate based on experience
BioSpace.com - 18 months ago