Clinical Safety Analyst – Maternity Replacement

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

📋 Description

• Triage incoming Serious Adverse Event (SAE) information to ensure timely reporting in accordance with regulatory and authority requirements.

• Engage in safety surveillance activities for designated products and contribute to area projects and objectives.

• Identify issues and escalate them to management as necessary.

• Collect, analyze, and triage Adverse Events, including the reporting of Serious Adverse Events to IND safety, along with necessary follow-ups.

• Conduct timely assessments of adverse event coding to ensure consistency and accuracy.

• Provide timely, precise, and effective medical reviews of safety-related case report forms (CRFs) and laboratory data, including communication with Study Designated Physicians.

• Collaborate with study managers, Clinical Research Organizations, Clinical Research Associates, Data Management, and Pharmacovigilance teams to ensure query resolution.

• Prepare narratives for serious adverse events and other relevant adverse events of interest, adhering to accepted standards with minimal revisions needed upon review.

• Work closely with study-specific contacts, including Clinical Safety Managers, clinical research organizations, clinical research associates, data management, and pharmacovigilance teams.

• Oversee the clinical safety capture and reporting, as responsibilities are study-related and significantly impact regulatory compliance and product safety profile.

• Follow scientific rationale and identify safety data needs, ensuring completeness regarding all aspects of clinical safety that influence product approval, safety signal identification, and patient safety.

⛳️ Requirements

• Bachelor's degree in a related health science field is preferred; RN or clinical pharmacy experience is strongly preferred.

• Candidates without the appropriate Bachelor's degree but with relevant pharmaceutical experience may also be considered.

• A minimum of 2 years of clinical experience is required.

• Strong understanding of ICH/FDA regulations and guidelines concerning drug safety issues.

• Comprehensive knowledge of product labeling and literature, including safety profiles.

• Ability to apply clinical knowledge to the collection and assessment of adverse event data.

• Competent in presenting adverse event data both verbally and in written format.

• Committed to adhering to policies and regulations.

• Proficient in computer applications (Windows, Word, Excel).

🏝️ Benefits

• Equal Opportunity Employer/Veterans/Disabled