Clinical Safety Analyst

🔥 6 minutes ago

🇷🇴 Romania – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧐 Analyst

👻 Ghost score 10%

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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

• Contribute to worldwide surveillance of clinical trial patient safety data and continuous improvement efforts • Provide timely assessment of reported clinical trial data and participate in safety surveillance activities for assigned studies • Review and analyze safety-related clinical trial data for content, quality, study-level trends, and adherence to regulatory guidance and protocols • Maintain constant audit readiness for study deliverables • Monitor safety-related queries to investigators • Collaborate with the medical monitor to plan and execute study safety reviews • Provide safety overviews to clinical teams, clinical research organizations, investigators, and investigator sites • Participate in study protocol reviews to ensure appropriate safety language • Review safety sections of clinical study reports and other ad-hoc safety reports • Create narratives of serious adverse events and other events of interest according to accepted standards • Serve on departmental process improvement projects as needed • Support AbbVie’s strategic direction by demonstrating its “Ways We Work” leadership behaviors

🎯 Requirements

• Bachelor's degree with related health science background • RN or clinical pharmacy experience strongly preferred • Minimum of 2 years’ experience, including at least 2 years of clinical practice experience • Preferred 1 year of drug safety experience with clinical trial life cycle management from pre-clinical to Phase III through launch to market • Proficiency in computers, including Windows, Word, and Excel • Proficiency in specific databases, such as Oracle/Clinical, PIMS, and laboratory databases • Ability to critically evaluate medical data, understanding clinical course and treatment modalities • Effective communication skills in delivering study-related information • Current knowledge of ICH, FDA, and EMA regulatory guidance affecting safety surveillance

🏖️ Benefits

• Equal opportunity employer • Committed to operating with integrity, driving innovation, transforming lives and serving the community

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