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Job Field: Security
Location: South San Francisco, CA
Salary: $Not stated

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>Sr. Drug Safety AssociateDrug Safety | South San Francisco, CA, United StatesSummary:The Senior Drug Safety Associate encompasses a key role in the day-to-day functioning of the Pharmacovigilance and Drug Safety department. Responsible for overseeing all aspects of adverse event processing and reporting for assigned investigational and marketed products, while also assisting management in establishing and implementing departmental strategy. Serves as a liaison to external healthcare providers, investigational sites, and company personnel for safety-related issues, working in close collaboration with colleagues from Clinical Science, Clinical Operations, Biometrics, Regulatory & QA, MedSA and Commercial.Essential/Primary Duties, Functions and Responsibilities Adverse Event Case Management Responsibilities:* Ensure that all safety reports received from any source (clinical trials and post-marketing) ,for assigned products and/or studies, are processed and reported according to ICH-GCP guidelines, regulatory requirements and company SOPs, policies and procedures.* Ensure that all domestic and foreign safety reports received by Onyx are appropriately triaged and scheduled in Onyx safety database based on the following criteria: source, seriousness, data entry priority, initial vs. follow-up report.* Ensure consistency in the initial evaluation and assessment of incoming case reports and source documentation for completeness, accuracy,& legibility.* Exercise judgment and use knowledge of FDA and ICH guidelines and product labeling in performing initial case assessment for seriousness and expectedness / listedness.* Ensure appropriateness of MedDRA and WHO-DD coding performed by Drug Safety staff.* Track all cases in the Workflow to manage departmental workload and to ensure adherence to processing timelines.* Assist with Quality Control reviews of others&rsquo; cases to ensure the accuracy, integrity and completeness of information entered into the safety database.* Liaise with assigned Physicians in Drug Safety, Clinical Science and/or MedSA to ensure that appropriate medical review and assessment is provided for assigned case reports.* Determine necessary follow-up for missing, discrepant or additional information/source documentation for each case using medical, product and regulatory knowledge* Perform follow-up (telephone, e-mail or facsimile), as needed, either directly with reporter, through Call Center, or through appropriate CRAs, and documents results in case file.* Ensure that required follow-up for assigned cases has been completed.* Communicate with partner companies, collaborative sponsors and their respective clinical research organizations (CROs) regarding the evaluation and processing of case reports.* Coordinates the distribution and submission of expedited and non-expedited individual case safety reports to regulatory authorities, partner companies, and other trading partners, as needed, to ensure compliance with regulatory and company timelines.Additional Safety Management Responsibilities:* Mentor and train Drug Safety Associate and Drug Safety Coordinators in the execution of their daily functions.* Set-up of new safety projects, including development of study-specific Safety Management Plans, set-up of safety systems, training of internal and external project-team members in safety-reporting processes, and presentations at investigator meetings.* Manage the collaboration with Data Management personnel to ensure that key data fields are reconciled between the clinical and safety databases.* Prepare periodic and annual safety reports and investigator communications.* Develop Patient Safety Narratives for final Clinical Study Reports, in conjunction with the appropriate Medical Writing and Data Management personnel, as needed.* Perform MedDRA , WHO-DD and other medical dictionary coding of clinical trial data from the clinical database in collaboration with Data Management and Clinical Science.* Review of aggreg

KEY REQUIREMENTS:

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