The Drug Safety Associate 2 encompasses a key role in the day-to-day functioning of the Pharmacovigilance and Drug Safety department. Responsible for all aspects of adverse event processing and reporting for assigned investigational and marketed products, while maintaining compliance with Onyx SOPs and FDA, ICH and worldwide regulations to ensure uniform and timely processing and reporting of adverse event reports. 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.
Adverse Event Processing & Reporting Responsibilities:
Process and distribute safety reports received from any source (clinical trials and post-marketing) for assigned products and/or studies, according to ICH-GCP guidelines, regulatory requirements and company SOPs, policies and procedures.
Assist in managing the triage domestic and foreign safety reports received by Onyx, appropriately scheduling case reports in Onyx safety database based on the following criteria: source, seriousness, data entry priority, initial vs. follow-up report.
Responsible for initial evaluation and assessment of incoming case reports and source documentation for completeness, accuracy, legibility, and consistency of information, and perform necessary checks for duplicate cases.
Exercise judgment and use knowledge of FDA and ICH guidelines and product labeling in performing initial case assessment for seriousness and expectedness / listedness.
Enter appropriate data into the Onyx safety database in a timely manner, utilizing management-determined data entry guidelines.
Generate narrative case summaries according to Onyx standards.
Code all adverse event terminology, other medical information, and drug information in Onyx safety database utilizing MedDRA and WHO-DD dictionaries, in accordance with Onyx coding policies and standards.
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.
Oversee the creation and maintenance of electronic and hard copy case files as per Onyx SOPs and guidelines.
Produce and distribute 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 Drug Safety Associate I and Drug Safety Coordinators in their daily functions, with emphasis on review of adverse event reports, follow-up with reporters to obtain necessary and appropriate follow-up information, and accurate coding of events using the MedDRA dictionary.
Collaborate with Data Management personnel to ensure that key data fields are reconciled between the clinical and safety databases and assists in resolving discrepancies.
Prepare periodic and annual safety reports and investigator communications.
Generate safety line listing reports, summary tabulations, and/or metric reports for company management, partner companies, and collaborative sponsors, as needed.
Develop Patient Safety Narratives for final Clinical Study Reports, in conjunction with the appropriate Medical Writing and Data Management personnel, as needed.
Assist with the 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.
Participate in Study Execution Team (SET) and similar meetings, representing the Drug Safety department
Other duties as assigned.
Departmental and Line Management Responsibilities:
Collaborate with department personnel to identify Drug Safety process needs and areas for improvement.
Assist in the development of departmental or cross functional SOPs, policies and working guidelines.
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.
2-3 years of Pharmacovigilance / Drug Safety experience or equivalent required, specifically in a global environment.
Oncology experience preferred
Functional/Technical Knowledge & Skills:
Knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing safety environments.
Understanding of medical terminology and familiarity with principles of clinical assessment of adverse events in the pharmaceutical industry.
Working knowledge of MedDRA dictionary with relevance to adverse event coding.
Extensive experience with software-based drug safety systems required, preferably ARISg.
Strong computer skills (MS Office)