Pharmacovigilance Associate
Ardea Biosciences - San Diego, CA

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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 and summary of safety 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

< > ulgt;
< > ligt;RN, BS/BA, and/ or Master’s degree in a health related field
< > ligt;Minimum 5 years of Biotech Industry experience; Pharmacovigilance experience preferred
< > ligt;Knowledge of FDA and international adverse event reporting regulations per ICH guidelines and the ability to interpret and apply applicable regulations to maintain compliance
< > ligt;Proficiency in strategizing, planning, monitoring and problem solving
< > ligt;Team-oriented with excellent communication and interpersonal skills, demonstrated ability in managing and influencing indirectly
< > ligt;Flexibility to work in a fast-paced environment. Ability to manage multiple and diverse tasks
< > ligt;Demonstrates accountability and attention to detail
< > ligt;Ability to prioritize, plan, and organize work assignments while working under strict timelines
< > ligt;Must have the ability to follow established processes and the flexibility to adopt new practices and priorities as required
< > ligt;Excellent oral and written communication skills
< > ligt;Excellent computer skills in the following programs: MS Word, PowerPoint, and Excel

Ardea Biosciences - 13 months ago - save job