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 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 aggregate safety data from the clinical database and generation of any necessary data queries in support of Data Monitoring Committee meetings, interim analyses or final database lock.
Participate in Study Execution Team (SET) and similar meetings, representing the Drug Safety department.
Other duties as assigned
Departmental and Line Management Responsibilities:
Develop departmental or cross functional SOPs, policies and working guidelines, as assigned by Management.
Assists management with the identification and evaluation of potential candidates for new-hire Drug Safety Associates and Drug Safety Coordinators.
Train appropriate Company personnel and external groups in pharmacovigilance and drug safety principles, SOPs and policies.
Assist with the maintenance of the ARISg safety database, including participation in validation and implementation activities for system upgrades and maintenance of the safety database user manual.
Contact departmental Management immediately if a regulatory agency has requested an inspection, or if there are any serious compliance observations within the Drug Safety department.
3-5 years of Pharmacovigilance / Drug Safety experience or equivalent required. Both pre-approval and post-marketing experience in a global environment highly desired.
Oncology experience preferred
Functional/Technical Knowledge & Skills:
Expert knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing safety environment
Working knowledge of the overall drug development proces
Extensive knowledge of medical terminology and principles of clinical assessment of adverse events in the pharmaceutical industry.
Expertise in MedDRA dictionary with relevance to adverse event coding.
Extensive experience with software-based drug safety systems required, preferably ARISg.
Strong computer skills (MS Office)