Senior Clinical Safety Analyst

Job not on LinkedIn

🔥 0 minutes ago

🌽 Illinois – Remote

🌽 Illinois – Remote

💵 $78.5k - $141k / year

⏰ Full Time

🟠 Senior

🧐 Analyst

🦅 H1B Visa Sponsor

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AbbVie

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2013

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

AbbVie is a global pharmaceutical company that discovers and delivers innovative medicines and solutions to enhance lives. With a focus on addressing the world's toughest health challenges, AbbVie operates in over 175 countries, providing a wide range of products across areas like immunology, oncology, neuroscience, and aesthetics. Committed to scientific innovation, AbbVie invests heavily in research and development, aiming to produce first-in-class medicines. The company also emphasizes workplace diversity, sustainability, and patient support initiatives, ensuring positive impact for both its patients and the broader community.

📋 Description

• Independently review safety-related clinical trial data for content, quality, and adherence to regulatory guidance and protocols • Collect, analyze, and triage adverse events • Participate in safety surveillance activities for assigned products • Plan and complete ad hoc safety reports • Assess adverse event coding for consistency and accuracy • Medically review safety-related CRFs and laboratory data • Communicate with Study Designated Physicians, study managers, CROs, CRAs, Data Management, Pharmacovigilance, and other stakeholders to resolve queries • Track safety-related queries to investigators and assist with IRB/IEC safety questions • Develop and implement Study Safety Review Plans • Provide safety overviews to clinical teams, CROs, investigators, and investigator sites • Review study protocols, IND reports, annual reports, Investigator Brochures, clinical report safety sections, monitoring plans, IDMC data, and other safety reports • Create narratives for serious adverse events and other events of interest • Apply ICH, FDA, and EMA regulations and guidelines to assigned responsibilities • Understand, implement, and improve department SOPs • Represent Safety Management on cross-functional projects without decision-making responsibility • Prioritize workload, train others, reconcile databases, and conduct safety surveillance • Troubleshoot problems and escalate appropriately to the manager • Mentor and coach designated Safety staff on assigned activities

🎯 Requirements

• 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 Windows, Word, Excel, Oracle/Clinical, PIMS, and laboratory databases • Ability to critically evaluate medical data • Ability to accurately and medically present case data orally and in writing • Ability to identify, prioritize, and assign tasks to others in the Clinical Safety Manager's absence • Ability to monitor problems through resolution • Ability to analyze and interpret adverse event data • Ability to exercise good judgment within policies and regulations • Effective communication skills in delivering study-related information

🏖️ Benefits

• Paid time off (vacation, holidays, sick) • Medical, dental, and vision insurance • 401(k) • Short-term incentive programs • Equal opportunity employer • Reasonable accommodations for applicants • Veterans/Disabled applicant support