Clinical Safety Analyst

This is a fully remote position, open to applicants in Romania.

📋 Description

• Contribute to global monitoring of clinical trial patient safety data and ongoing improvement initiatives.

• Provide prompt evaluations of reported clinical trial data and engage in safety monitoring activities for designated studies.

• Review and assess safety-related clinical trial data for content, quality, study-level trends, and compliance with regulatory guidelines and protocols.

• Ensure continuous audit readiness for study deliverables.

• Track safety-related inquiries directed to investigators.

• Collaborate with the medical monitor to plan and implement study safety reviews.

• Deliver safety overviews to clinical teams, clinical research organizations, investigators, and investigator sites.

• Participate in reviewing study protocols to guarantee appropriate safety language.

• Examine safety sections of clinical study reports and other ad-hoc safety documents.

• Draft narratives of serious adverse events and other notable events in accordance with accepted standards.

• Engage in departmental process improvement projects as necessary.

• Support AbbVie’s strategic direction by exemplifying its “Ways We Work” leadership behaviors.

⛳️ Requirements

• Bachelor's degree with a relevant health science background.

• RN or clinical pharmacy experience is highly preferred.

• At least 2 years of experience, including a minimum of 2 years in clinical practice.

• Ideally, 1 year of drug safety experience encompassing clinical trial life cycle management from pre-clinical through Phase III to market launch.

• Proficient in computer applications, including Windows, Word, and Excel.

• Familiarity with specific databases, such as Oracle/Clinical, PIMS, and laboratory databases.

• Ability to critically assess medical data, comprehending clinical courses and treatment options.

• Strong communication skills for effectively conveying study-related information.

• Up-to-date knowledge of ICH, FDA, and EMA regulatory guidelines impacting safety surveillance.

🏝️ Benefits

• Equal opportunity employer.

• Dedicated to operating with integrity, fostering innovation, transforming lives, and serving the community.