Senior, Clinical Safety Analyst/Immuno
Independently reviews safety-related data from clinical trials for content, quality, adherence to regulatory guidance and protocols by collecting, analyzing, and triaging Adverse Events as this position impacts product approval, safety signal identification, and patient safety.
Key Responsibilities Include:
- Participates in applicable safety surveillance activities for assigned products; and in planning and completion of Ad-Hoc Safety Reports as needed.
- Timely assessment of adverse event coding for consistency and accuracy of coding and ; accurate and effective medical review of safety-related CRFs and labs, including communication with Study Designated Physicians by interfacing with study manager, Clinical Research Organizations, Clinical Research Associates, Data Management, Pharmacovigilance and others to assure query resolution.
- Supervise tracking of safety -related queries to Investigators and assists in handling safety questions from Institutional Review Board/Independent Ethics Committee (IRB/IEC).
- Assist with Study Safety Review Plan development and implementation in collaboration with Study Designated Physicians and provides Safety overview to Clinical team members, Clinical Research Organizations, Investigators and investigator sites as needed and review study protocols, IND reports, annual reports, Investigator Brochures, Safety sections of the Clinical Reports, Monitoring Plans, IDMC data and other ad hoc reports which include safety data.
- Create narratives of serious adverse events and other identified events of interest in accordance with accepted standards and with high degree of competency.
- Apply knowledge of ICH, FDA, EMA regulations and guidelines affecting drug and disease state, understanding issues to assigned responsibilities with an in depth understanding of product labeling/literature, including safety profile. Understand, implements and improves department SOPs. Clinical knowledge to apply to adverse event data collection and assessment.
- May serve as a representative for Safety Management on cross-functional projects, but does not assume decision-making responsibilities in the representative role; Contacts may include Clinical Safety Manager and a variety of multidisciplinary representatives (e.g. Regulatory Affairs, Quality Assurance, Compliance).
- Does not initiate strategic decisions, but is responsible for supporting the department, division and company's strategic direction.
- Workload responsibilities are primarily study-related and include some safety higher level functioning (e.g. prioritizing workload, training, reconciliation of databases, safety surveillance). Troubleshoots problems. Problem solving involves identification of problems and proper escalation to manager.
- Starts to mentor/teach others with directions from lead mentor or team manager. Assists in mentoring staff by coaching and mentoring designated Safety staff on assigned safety activities.
- Bachelor's degree with related health science background is required. RN or clinical pharmacy experience strongly preferred. Candidates lacking the appropriate Bachelor's degree but with previous pharma experience may be additionally considered.
- Minimum 3 years clinical experience with a minimum of 1 year drug safety/pharma experience (or) 2 years clinical experience with a minimum of 3 years drug safety/pharma experience.
- Proficiency in Computers (Windows, Word, Excel) and in specific databases (e.g., oracle/clinical, PIMS, laboratory databases).
- Ability to critically evaluate medical data.
- Ability in accurately and medically presenting; of case data, both orally and in writing.
- Ability to identify, prioritize and assign tasks to others in Clinical Safety Manager's absence.
- Monitor problems through resolution.
- Analyze and interpret adverse event data as a component of clinical surveillance activity.
- Consistently exercise good judgment within policies and regulations.
- Effective communication skills in delivering study-related information.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
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